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S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer

Primary Purpose

Metastatic Pancreatic Adenocarcinoma

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PEGPH20
Oxaliplatin
Leucovorin
Irinotecan
5-fluorouracil
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Patients must have newly diagnosed, untreated metastatic histologically or cytologically documented pancreatic adenocarcinoma; patients must not have known history of brain metastases
  • Patients must have measurable metastatic disease; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; CT scans or MRIs must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
  • Patients must not have had any prior treatment with oxaliplatin or irinotecan within 3 years prior to registration; patients must not have had prior chemotherapy in metastatic setting; prior abdominal radiation therapy is not allowed
  • Patients must have a Zubrod performance status of 0-1
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Hemoglobin >= 9 g/dL
  • Total bilirubin =< institutional upper limit of normal (IULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 2.5 X IULN in the absence of liver metastases or =< 5.0 x IULN with liver metastasis
  • Serum albumin >= 3 g/dL
  • Serum creatinine =< ULN within 14 days prior to registration OR calculated creatinine clearance > 50 ml/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to registration
  • Patients must have international normalized ratio (INR) =< 1.2 within 14 days prior to registration; patients must not be receiving warfarin for therapeutic use, have history of cerebrovascular accident (CVA), history of transient ischemic attack (TIA) requiring intervention or treatment, pre-existing carotid artery disease requiring intervention or treatment, or current use of megestrol acetate (use within 10 days of registration)
  • Patients must not be receiving chronic treatment (equivalent of prednisone > 10 mg/day) with systemic steroids or other immuno-suppressive agent
  • Patients must not have liver disease such a cirrhosis, chronic active hepatitis or chronic persistent hepatitis
  • Patients must not have active bleeding or a pathological condition that is associated with a high risk of bleeding
  • Patients with a known history of human immunodeficiency virus (HIV) must not be on active treatment for HIV
  • Patients must have no non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with protocol therapy
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
  • Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patients must have tumor (paraffin block or slides) available for submission and be willing to submit tumor and blood samples
  • Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • Patients planning to enroll in the phase I portion of this study must first have a slot reserved in advance of the registration; all site staff will use OPEN to create a slot reservation

Sites / Locations

  • Anchorage Associates in Radiation Medicine
  • Alaska Breast Care and Surgery LLC
  • Alaska Women's Cancer Care
  • Katmai Oncology Group
  • Providence Alaska Medical Center
  • University of Arizona Cancer Center-North Campus
  • The University of Arizona Medical Center-University Campus
  • Sutter Auburn Faith Hospital
  • Sutter Cancer Centers Radiation Oncology Services-Auburn
  • Alta Bates Summit Medical Center-Herrick Campus
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • Mills - Peninsula Hospitals
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
  • Eden Hospital Medical Center
  • City of Hope Corona
  • UC Irvine Health Cancer Center-Newport
  • Sutter Davis Hospital
  • City of Hope Comprehensive Cancer Center
  • Los Angeles County-USC Medical Center
  • USC / Norris Comprehensive Cancer Center
  • Fremont - Rideout Cancer Center
  • Memorial Medical Center
  • Palo Alto Medical Foundation-Camino Division
  • Palo Alto Medical Foundation-Gynecologic Oncology
  • Sutter Cancer Research Consortium
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
  • Palo Alto Medical Foundation Health Care
  • Sutter Cancer Centers Radiation Oncology Services-Roseville
  • Sutter Roseville Medical Center
  • Sutter General Hospital
  • University of California Davis Comprehensive Cancer Center
  • California Pacific Medical Center-Pacific Campus
  • Palo Alto Medical Foundation-Santa Cruz
  • Sutter Pacific Medical Foundation
  • Palo Alto Medical Foundation-Sunnyvale
  • Gene Upshaw Memorial Tahoe Forest Cancer Center
  • Sutter Cancer Centers Radiation Oncology Services-Vacaville
  • Sutter Solano Medical Center/Cancer Center
  • City of Hope West Covina
  • Smilow Cancer Hospital-Derby Care Center
  • Smilow Cancer Hospital Care Center-Fairfield
  • Medical Oncology and Hematology Group PC-Guilford
  • Smilow Cancer Hospital Care Center at Saint Francis
  • Smilow Cancer Center/Yale-New Haven Hospital
  • Yale University
  • Yale-New Haven Hospital North Haven Medical Center
  • Smilow Cancer Hospital-Orange Care Center
  • Charlotte Hungerford Hospital Center for Cancer Care
  • Smilow Cancer Hospital Care Center-Trumbull
  • Smilow Cancer Hospital-Waterbury Care Center
  • Saint Luke's Mountain States Tumor Institute
  • Saint Luke's Mountain States Tumor Institute - Fruitland
  • Saint Luke's Mountain States Tumor Institute - Meridian
  • Saint Luke's Mountain States Tumor Institute - Nampa
  • Saint Luke's Mountain States Tumor Institute-Twin Falls
  • Saint Joseph Medical Center
  • Illinois CancerCare-Bloomington
  • Illinois CancerCare-Canton
  • Memorial Hospital of Carbondale
  • Illinois CancerCare-Carthage
  • Centralia Oncology Clinic
  • Cancer Care Center of Decatur
  • Decatur Memorial Hospital
  • Crossroads Cancer Center
  • Illinois CancerCare-Eureka
  • Illinois CancerCare-Galesburg
  • Western Illinois Cancer Treatment Center
  • Illinois CancerCare-Kewanee Clinic
  • Illinois CancerCare-Macomb
  • Illinois CancerCare-Ottawa Clinic
  • Radiation Oncology of Northern Illinois
  • Illinois CancerCare-Pekin
  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
  • Methodist Medical Center of Illinois
  • Illinois CancerCare-Peoria
  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
  • OSF Saint Francis Medical Center
  • Illinois CancerCare-Peru
  • Valley Radiation Oncology
  • Illinois CancerCare-Princeton
  • Central Illinois Hematology Oncology Center
  • Southern Illinois University School of Medicine
  • Springfield Clinic
  • Memorial Medical Center
  • Cancer Care Specialists of Illinois-Swansea
  • Kansas Institute of Medicine Cancer and Blood Center
  • Minimally Invasive Surgery Hospital
  • Menorah Medical Center
  • Saint Luke's South Hospital
  • Kansas City NCI Community Oncology Research Program
  • Wayne State University/Karmanos Cancer Institute
  • Weisberg Cancer Treatment Center
  • Parkland Health Center-Bonne Terre
  • Saint Francis Medical Center
  • Southeast Cancer Center
  • Centerpoint Medical Center LLC
  • Capital Region Medical Center-Goldschmidt Cancer Center
  • Saint Luke's Hospital of Kansas City
  • Heartland Hematology and Oncology Associates Incorporated
  • Research Medical Center
  • Saint Luke's East - Lee's Summit
  • Liberty Radiation Oncology Center
  • Heartland Regional Medical Center
  • Missouri Baptist Medical Center
  • Sainte Genevieve County Memorial Hospital
  • Missouri Baptist Sullivan Hospital
  • Missouri Baptist Outpatient Center-Sunset Hills
  • Randolph Hospital
  • Cone Health Cancer Center at Alamance Regional
  • Southeastern Medical Oncology Center-Clinton
  • Southeastern Medical Oncology Center-Goldsboro
  • Wayne Memorial Hospital
  • Cone Health Cancer Center
  • Hendersonville Hematology and Oncology at Pardee
  • Margaret R Pardee Memorial Hospital
  • Southeastern Medical Oncology Center-Jacksonville
  • Cone Heath Cancer Center at Mebane
  • Annie Penn Memorial Hospital
  • Southeastern Medical Oncology Center-Wilson
  • University of Oklahoma Health Sciences Center
  • Saint Charles Health System
  • Clackamas Radiation Oncology Center
  • Providence Oncology and Hematology Care Southeast
  • Bay Area Hospital
  • Providence Newberg Medical Center
  • Providence Willamette Falls Medical Center
  • Providence Portland Medical Center
  • Providence Saint Vincent Medical Center
  • Medical University of South Carolina
  • Providence Regional Cancer System-Aberdeen
  • Cancer Care Center at Island Hospital
  • PeaceHealth Saint Joseph Medical Center
  • Providence Regional Cancer System-Centralia
  • Swedish Medical Center-Edmonds
  • Providence Regional Cancer Partnership
  • Swedish Cancer Institute-Issaquah
  • Kadlec Clinic Hematology and Oncology
  • Seattle Cancer Care Alliance at EvergreenHealth
  • Providence Regional Cancer System-Lacey
  • PeaceHealth Saint John Medical Center
  • Minor and James Medical PLLC
  • Pacific Gynecology Specialists
  • Swedish Medical Center-Ballard Campus
  • Fred Hutchinson Cancer Research Center
  • Seattle Cancer Care Alliance
  • Group Health Cooperative-Seattle
  • Swedish Medical Center-First Hill
  • University of Washington Medical Center
  • Providence Regional Cancer System-Shelton
  • Rockwood Clinic Cancer Treatment Center-Valley
  • Rockwood Cancer Treatment Center-DHEC-Downtown
  • PeaceHealth Southwest Medical Center
  • Providence Saint Mary Regional Cancer Center
  • Providence Regional Cancer System-Yelm

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Phase II: mFOLFIRINOX

Phase II: mFOLFIRINOX + PEGPH20

Phase I

Arm Description

Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Patients receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes; Oxaliplatin, 85 mg/m^2, on Day 2, IV over 2 hours; Leucovorin, 400 mg/m^2, on Day 2, IV over 2 hours; Irinotecan, 180 mg/m^2, on Day 2, IV over 1.5 hours; 5-fluorouracil (5-FU), 2,400 mg/m^2, Days 2-4, IV over 46 hours

Outcomes

Primary Outcome Measures

Phase I: Maximum Tolerated Dose (MTD) of PEGPH20 in Combination With mFOLFIRINOX
Assess safety of mFOLFIRINOX in combination with PEGPH20 and select the optimal dose of PEGPH20 for the Phase II portion. MTD of PEGPH20 in combination with mFOLFORINOX was evaluated by testing decreasing doses of PEGPH20 from 3mcg/kg on Day 1 and Day 3/4, to 3mcg/kg on Day 1 only and to 1.6 mcg/kg on Day 1 only. MTD reflects the highest dose that had a dose-limiting toxicity (DLT) rate of ≤ 17%. DLTs were defined as treatment regimen related: grade ≥ 3 non-hematologic toxicity; grade 4 absolute neutrophil count (ANC) anemia or thrombocytopenia; grade 4 ANC lasting > 7 days; grade ≥ 3 febrile neutropenia; grade ≥ 3 elevation of aspartate aminotransferase (AST)/alanine aminotransferase (ALT), total bilirubin, and creatinine; delay in starting the 2nd cycle of mFOLFIRINOX by > 2 weeks due to drug related toxicity. DLT were graded using the NCI CTCAE version 4. Note: the third and lowest dose level was not reached.
Phase II: Overall Survival
Time from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact. Assessed using the logrank test.

Secondary Outcome Measures

Progression Free Survival (PFS) (Phase II)
Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact.
Objective Tumor Response Rate (Confirmed and Unconfirmed, Complete and Partial)
Objective tumor response rate (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living e.g. bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event

Full Information

First Posted
September 30, 2013
Last Updated
September 12, 2023
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Halozyme Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01959139
Brief Title
S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer
Official Title
S1313, A Phase IB/II Randomized Study of Modified FOLFIRINOX + Pegylated Recombinant Human Hyaluronidase (PEGPH20) Versus Modified FOLFIRINOX Alone in Patients With Good Performance Status Metastatic Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 23, 2014 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI), Halozyme Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This partially randomized phase I/II trial studies the side effects and best dose of pegylated recombinant human hyaluronidase (PEGPH20) when given together with combination chemotherapy and to see how well they work compared with combination chemotherapy alone in treating patients with newly diagnosed pancreatic cancer that has spread to other places in the body. Pegylated recombinant human hyaluronidase may help chemotherapy drugs work better by making tumor cells more sensitive to the drugs. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether combination chemotherapy is more effective with or without pegylated recombinant human hyaluronidase in treating pancreatic cancer.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the safety of modified leucovorin calcium, fluorouracil, irinotecan hydrochloride and oxaliplatin (mFOLFIRINOX) in combination with PEGPH20 and select the optimal dose of PEGPH20 for the phase II portion in patients with metastatic pancreatic adenocarcinoma. (Phase I) II. To assess the overall survival of patients with metastatic pancreatic adenocarcinoma treated with mFOLFIRINOX + PEGPH20 compared to those treated with mFOLFIRINOX alone. (Phase II) SECONDARY OBJECTIVES: I. To assess progression free survival (PFS) in patients receiving mFOLFIRINOX with PEGPH20 and patients receiving mFOLFIRINOX alone in this patient population. II. To assess objective tumor response (confirmed and unconfirmed, complete and partial) in patients with measurable disease treated with mFOLFIRINOX with PEGPH20 and patients receiving mFOLFIRINOX alone in this patient population. III. To determine the frequency, severity, and tolerability of adverse events of mFOLFIRINOX with PEGPH20. TERTIARY OBJECTIVES: I. To explore the correlation of maximum decrease in cancer antigen (CA) 19-9 levels and time to maximum decrease in CA 19-9 levels with overall survival, progression-free survival and response. II. To explore the correlation of plasma hyaluronan (HA) and tumor expression of HA with overall survival, progression-free survival and response. OUTLINE: This is a phase I, dose de-escalation study of pegylated recombinant human hyaluronidase followed by a randomized phase II study. PHASE I: Patients receive pegylated recombinant human hyaluronidase intravenously (IV) over 10 minutes on day 1*; oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2; and fluorouracil IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. PHASE II: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and fluorouracil IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive pegylated recombinant human hyaluronidase IV over 10 minutes on day 1* and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and fluorouracil as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. *NOTE: Some patients also receive pegylated recombinant human hyaluronidase on day 3 or 4 of courses 1 and 2. After completion of study treatment, patients are followed up for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase II: mFOLFIRINOX
Arm Type
Active Comparator
Arm Description
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and irinotecan hydrochloride IV over 1.5 hours on day 2, and 5-fluorouracil (5-FU) IV over 46 hours on days 2-4. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Arm Title
Phase II: mFOLFIRINOX + PEGPH20
Arm Type
Experimental
Arm Description
Patients receive pegylated recombinant human hyaluronidase (PEGPH20) IV over 10 minutes on day 1 and oxaliplatin, leucovorin calcium, irinotecan hydrochloride, and 5-fluorouracil (5-FU) as in Arm I. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Arm Title
Phase I
Arm Type
Experimental
Arm Description
PEGPH20, 3 ug/kg on Day 1 and Day 3/4, IV over 15 minutes; Oxaliplatin, 85 mg/m^2, on Day 2, IV over 2 hours; Leucovorin, 400 mg/m^2, on Day 2, IV over 2 hours; Irinotecan, 180 mg/m^2, on Day 2, IV over 1.5 hours; 5-fluorouracil (5-FU), 2,400 mg/m^2, Days 2-4, IV over 46 hours
Intervention Type
Drug
Intervention Name(s)
PEGPH20
Other Intervention Name(s)
Pegylated Recombinant Human Hyaluronidase
Intervention Description
3 ug/kg on Day 1, IV over 15 minutes
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin, NSC-266046
Intervention Description
85 mg/m^2, on Day 2, IV over 2 hours
Intervention Type
Drug
Intervention Name(s)
Leucovorin
Other Intervention Name(s)
leucovorin calcium
Intervention Description
400 mg/m^2, on Day 2, IV over 2 hours
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
CPT-11, NSC-616348
Intervention Description
180 mg/m^2, on Day 2, IV over 1.5 hours
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Other Intervention Name(s)
5-FU, Adrucil, NSC-19893
Intervention Description
2,400 mg/m^2, Days 2-4, IV over 46 hours
Primary Outcome Measure Information:
Title
Phase I: Maximum Tolerated Dose (MTD) of PEGPH20 in Combination With mFOLFIRINOX
Description
Assess safety of mFOLFIRINOX in combination with PEGPH20 and select the optimal dose of PEGPH20 for the Phase II portion. MTD of PEGPH20 in combination with mFOLFORINOX was evaluated by testing decreasing doses of PEGPH20 from 3mcg/kg on Day 1 and Day 3/4, to 3mcg/kg on Day 1 only and to 1.6 mcg/kg on Day 1 only. MTD reflects the highest dose that had a dose-limiting toxicity (DLT) rate of ≤ 17%. DLTs were defined as treatment regimen related: grade ≥ 3 non-hematologic toxicity; grade 4 absolute neutrophil count (ANC) anemia or thrombocytopenia; grade 4 ANC lasting > 7 days; grade ≥ 3 febrile neutropenia; grade ≥ 3 elevation of aspartate aminotransferase (AST)/alanine aminotransferase (ALT), total bilirubin, and creatinine; delay in starting the 2nd cycle of mFOLFIRINOX by > 2 weeks due to drug related toxicity. DLT were graded using the NCI CTCAE version 4. Note: the third and lowest dose level was not reached.
Time Frame
2 cycles of 14 days
Title
Phase II: Overall Survival
Description
Time from date of registration to date of death due to any cause. Participants last known to be alive are censored at date of last contact. Assessed using the logrank test.
Time Frame
From date of registration to date of death due to any cause, assessed up to 3 years
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) (Phase II)
Description
Time from date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact.
Time Frame
From date of registration to date of death due to any cause, assessed up to 3 years
Title
Objective Tumor Response Rate (Confirmed and Unconfirmed, Complete and Partial)
Description
Objective tumor response rate (complete response, unconfirmed complete response, partial response, unconfirmed partial response) in patients with measurable disease were assessed in each arm and compared between arms using Chi-squared test. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions
Time Frame
Up to 3 years
Title
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Description
Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living e.g. bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to adverse event
Time Frame
Duration of treatment and follow up until death or 3 years post registration
Other Pre-specified Outcome Measures:
Title
Cancer Antigen (CA) 19-9 Levels
Description
Explore correlation of maximum decrease in CA 19-9 levels to maximum decrease in CA 19-9 levels with overall survival, progression-free survival and response.
Time Frame
Within 2 years of the end of the study
Title
Plasma Expression of Hyaluronan (HA)
Time Frame
Within 2 years of end of study
Title
Tumor Expression of HA
Time Frame
Within 2 years of end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients must have newly diagnosed, untreated metastatic histologically or cytologically documented pancreatic adenocarcinoma; patients must not have known history of brain metastases Patients must have measurable metastatic disease; computed tomography (CT) scans or magnetic resonance imaging (MRI)s used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; CT scans or MRIs must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) Patients must not have had any prior treatment with oxaliplatin or irinotecan within 3 years prior to registration; patients must not have had prior chemotherapy in metastatic setting; prior abdominal radiation therapy is not allowed Patients must have a Zubrod performance status of 0-1 Absolute neutrophil count (ANC) >= 1,500/mcL Platelets >= 100,000/mcL Hemoglobin >= 9 g/dL Total bilirubin =< institutional upper limit of normal (IULN) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 2.5 X IULN in the absence of liver metastases or =< 5.0 x IULN with liver metastasis Serum albumin >= 3 g/dL Serum creatinine =< ULN within 14 days prior to registration OR calculated creatinine clearance > 50 ml/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to registration Patients must have international normalized ratio (INR) =< 1.2 within 14 days prior to registration; patients must not be receiving warfarin for therapeutic use, have history of cerebrovascular accident (CVA), history of transient ischemic attack (TIA) requiring intervention or treatment, pre-existing carotid artery disease requiring intervention or treatment, or current use of megestrol acetate (use within 10 days of registration) Patients must not be receiving chronic treatment (equivalent of prednisone > 10 mg/day) with systemic steroids or other immuno-suppressive agent Patients must not have liver disease such a cirrhosis, chronic active hepatitis or chronic persistent hepatitis Patients must not have active bleeding or a pathological condition that is associated with a high risk of bleeding Patients with a known history of human immunodeficiency virus (HIV) must not be on active treatment for HIV Patients must have no non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with protocol therapy No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years Patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures Patients must have tumor (paraffin block or slides) available for submission and be willing to submit tumor and blood samples Patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system Patients planning to enroll in the phase I portion of this study must first have a slot reserved in advance of the registration; all site staff will use OPEN to create a slot reservation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramesh K Ramanathan, M.D.
Organizational Affiliation
Virginia G. Piper Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Anchorage Associates in Radiation Medicine
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
98508
Country
United States
Facility Name
Alaska Breast Care and Surgery LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Women's Cancer Care
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Katmai Oncology Group
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
University of Arizona Cancer Center-North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
The University of Arizona Medical Center-University Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Sutter Auburn Faith Hospital
City
Auburn
State/Province
California
ZIP/Postal Code
95602
Country
United States
Facility Name
Sutter Cancer Centers Radiation Oncology Services-Auburn
City
Auburn
State/Province
California
ZIP/Postal Code
95603
Country
United States
Facility Name
Alta Bates Summit Medical Center-Herrick Campus
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Mills - Peninsula Hospitals
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
City
Cameron Park
State/Province
California
ZIP/Postal Code
95682
Country
United States
Facility Name
Eden Hospital Medical Center
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
City of Hope Corona
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
UC Irvine Health Cancer Center-Newport
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Sutter Davis Hospital
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Los Angeles County-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Fremont - Rideout Cancer Center
City
Marysville
State/Province
California
ZIP/Postal Code
95901
Country
United States
Facility Name
Memorial Medical Center
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
Facility Name
Palo Alto Medical Foundation-Camino Division
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Palo Alto Medical Foundation-Gynecologic Oncology
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Sutter Cancer Research Consortium
City
Novato
State/Province
California
ZIP/Postal Code
94945
Country
United States
Facility Name
UC Irvine Health/Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Palo Alto Medical Foundation Health Care
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Facility Name
Sutter Cancer Centers Radiation Oncology Services-Roseville
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sutter Roseville Medical Center
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Sutter General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
California Pacific Medical Center-Pacific Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Palo Alto Medical Foundation-Santa Cruz
City
Santa Cruz
State/Province
California
ZIP/Postal Code
95065
Country
United States
Facility Name
Sutter Pacific Medical Foundation
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Palo Alto Medical Foundation-Sunnyvale
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94086
Country
United States
Facility Name
Gene Upshaw Memorial Tahoe Forest Cancer Center
City
Truckee
State/Province
California
ZIP/Postal Code
96161
Country
United States
Facility Name
Sutter Cancer Centers Radiation Oncology Services-Vacaville
City
Vacaville
State/Province
California
ZIP/Postal Code
95687
Country
United States
Facility Name
Sutter Solano Medical Center/Cancer Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
City of Hope West Covina
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Smilow Cancer Hospital-Derby Care Center
City
Derby
State/Province
Connecticut
ZIP/Postal Code
06418
Country
United States
Facility Name
Smilow Cancer Hospital Care Center-Fairfield
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
Medical Oncology and Hematology Group PC-Guilford
City
Guilford
State/Province
Connecticut
ZIP/Postal Code
06437
Country
United States
Facility Name
Smilow Cancer Hospital Care Center at Saint Francis
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Smilow Cancer Center/Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Yale-New Haven Hospital North Haven Medical Center
City
North Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Facility Name
Smilow Cancer Hospital-Orange Care Center
City
Orange
State/Province
Connecticut
ZIP/Postal Code
06477
Country
United States
Facility Name
Charlotte Hungerford Hospital Center for Cancer Care
City
Torrington
State/Province
Connecticut
ZIP/Postal Code
06790
Country
United States
Facility Name
Smilow Cancer Hospital Care Center-Trumbull
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
Facility Name
Smilow Cancer Hospital-Waterbury Care Center
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Saint Luke's Mountain States Tumor Institute-Twin Falls
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Saint Joseph Medical Center
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61701
Country
United States
Facility Name
Illinois CancerCare-Bloomington
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Illinois CancerCare-Canton
City
Canton
State/Province
Illinois
ZIP/Postal Code
61520
Country
United States
Facility Name
Memorial Hospital of Carbondale
City
Carbondale
State/Province
Illinois
ZIP/Postal Code
62902
Country
United States
Facility Name
Illinois CancerCare-Carthage
City
Carthage
State/Province
Illinois
ZIP/Postal Code
62321
Country
United States
Facility Name
Centralia Oncology Clinic
City
Centralia
State/Province
Illinois
ZIP/Postal Code
62801
Country
United States
Facility Name
Cancer Care Center of Decatur
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Crossroads Cancer Center
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Facility Name
Illinois CancerCare-Eureka
City
Eureka
State/Province
Illinois
ZIP/Postal Code
61530
Country
United States
Facility Name
Illinois CancerCare-Galesburg
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Western Illinois Cancer Treatment Center
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Illinois CancerCare-Kewanee Clinic
City
Kewanee
State/Province
Illinois
ZIP/Postal Code
61443
Country
United States
Facility Name
Illinois CancerCare-Macomb
City
Macomb
State/Province
Illinois
ZIP/Postal Code
61455
Country
United States
Facility Name
Illinois CancerCare-Ottawa Clinic
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Radiation Oncology of Northern Illinois
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Facility Name
Illinois CancerCare-Pekin
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
City
Pekin
State/Province
Illinois
ZIP/Postal Code
61554
Country
United States
Facility Name
Methodist Medical Center of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61603
Country
United States
Facility Name
Illinois CancerCare-Peoria
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
OSF Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Illinois CancerCare-Peru
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Valley Radiation Oncology
City
Peru
State/Province
Illinois
ZIP/Postal Code
61354
Country
United States
Facility Name
Illinois CancerCare-Princeton
City
Princeton
State/Province
Illinois
ZIP/Postal Code
61356
Country
United States
Facility Name
Central Illinois Hematology Oncology Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Springfield Clinic
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Cancer Care Specialists of Illinois-Swansea
City
Swansea
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Facility Name
Kansas Institute of Medicine Cancer and Blood Center
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Minimally Invasive Surgery Hospital
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Menorah Medical Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Saint Luke's South Hospital
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
Kansas City NCI Community Oncology Research Program
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Weisberg Cancer Treatment Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Parkland Health Center-Bonne Terre
City
Bonne Terre
State/Province
Missouri
ZIP/Postal Code
63628
Country
United States
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Southeast Cancer Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Centerpoint Medical Center LLC
City
Independence
State/Province
Missouri
ZIP/Postal Code
64057
Country
United States
Facility Name
Capital Region Medical Center-Goldschmidt Cancer Center
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Heartland Hematology and Oncology Associates Incorporated
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64118
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Saint Luke's East - Lee's Summit
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64086
Country
United States
Facility Name
Liberty Radiation Oncology Center
City
Liberty
State/Province
Missouri
ZIP/Postal Code
64068
Country
United States
Facility Name
Heartland Regional Medical Center
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Missouri Baptist Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Sainte Genevieve County Memorial Hospital
City
Sainte Genevieve
State/Province
Missouri
ZIP/Postal Code
63670
Country
United States
Facility Name
Missouri Baptist Sullivan Hospital
City
Sullivan
State/Province
Missouri
ZIP/Postal Code
63080
Country
United States
Facility Name
Missouri Baptist Outpatient Center-Sunset Hills
City
Sunset Hills
State/Province
Missouri
ZIP/Postal Code
63127
Country
United States
Facility Name
Randolph Hospital
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Cone Health Cancer Center at Alamance Regional
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Southeastern Medical Oncology Center-Clinton
City
Clinton
State/Province
North Carolina
ZIP/Postal Code
28328
Country
United States
Facility Name
Southeastern Medical Oncology Center-Goldsboro
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Wayne Memorial Hospital
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Cone Health Cancer Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Hendersonville Hematology and Oncology at Pardee
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
Margaret R Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
Southeastern Medical Oncology Center-Jacksonville
City
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
Country
United States
Facility Name
Cone Heath Cancer Center at Mebane
City
Mebane
State/Province
North Carolina
ZIP/Postal Code
27302
Country
United States
Facility Name
Annie Penn Memorial Hospital
City
Reidsville
State/Province
North Carolina
ZIP/Postal Code
27320
Country
United States
Facility Name
Southeastern Medical Oncology Center-Wilson
City
Wilson
State/Province
North Carolina
ZIP/Postal Code
27893
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Saint Charles Health System
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Clackamas Radiation Oncology Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Providence Oncology and Hematology Care Southeast
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Bay Area Hospital
City
Coos Bay
State/Province
Oregon
ZIP/Postal Code
97420
Country
United States
Facility Name
Providence Newberg Medical Center
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Facility Name
Providence Willamette Falls Medical Center
City
Oregon City
State/Province
Oregon
ZIP/Postal Code
97045
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Providence Regional Cancer System-Aberdeen
City
Aberdeen
State/Province
Washington
ZIP/Postal Code
98520
Country
United States
Facility Name
Cancer Care Center at Island Hospital
City
Anacortes
State/Province
Washington
ZIP/Postal Code
98221
Country
United States
Facility Name
PeaceHealth Saint Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Providence Regional Cancer System-Centralia
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States
Facility Name
Swedish Medical Center-Edmonds
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Swedish Cancer Institute-Issaquah
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Seattle Cancer Care Alliance at EvergreenHealth
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Providence Regional Cancer System-Lacey
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Facility Name
PeaceHealth Saint John Medical Center
City
Longview
State/Province
Washington
ZIP/Postal Code
98632
Country
United States
Facility Name
Minor and James Medical PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Pacific Gynecology Specialists
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Medical Center-Ballard Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98107
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Group Health Cooperative-Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Providence Regional Cancer System-Shelton
City
Shelton
State/Province
Washington
ZIP/Postal Code
98584
Country
United States
Facility Name
Rockwood Clinic Cancer Treatment Center-Valley
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Facility Name
Rockwood Cancer Treatment Center-DHEC-Downtown
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
PeaceHealth Southwest Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Providence Saint Mary Regional Cancer Center
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
Providence Regional Cancer System-Yelm
City
Yelm
State/Province
Washington
ZIP/Postal Code
98597
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30817250
Citation
Ramanathan RK, McDonough SL, Philip PA, Hingorani SR, Lacy J, Kortmansky JS, Thumar J, Chiorean EG, Shields AF, Behl D, Mehan PT, Gaur R, Seery T, Guthrie KA, Hochster HS. Phase IB/II Randomized Study of FOLFIRINOX Plus Pegylated Recombinant Human Hyaluronidase Versus FOLFIRINOX Alone in Patients With Metastatic Pancreatic Adenocarcinoma: SWOG S1313. J Clin Oncol. 2019 May 1;37(13):1062-1069. doi: 10.1200/JCO.18.01295. Epub 2019 Feb 28.
Results Reference
derived

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S1313, PEGPH20 in Treating Patients With Newly Diagnosed Metastatic Pancreatic Cancer

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