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Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma (PrE0204)

Primary Purpose

Cholangiocarcinoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nab-Paclitaxel and Gemcitabine
Sponsored by
PrECOG, LLC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma focused on measuring Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma, CCA, Bile Duct Cancer, Nab-Paclitaxel, Abraxane®, Gemcitabine, Gemzar®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must have histologically-confirmed diagnosis of cholangiocarcinoma Stage II, III, or IV CCA (intra-hepatic, extra-hepatic and perihilar) that is not eligible for curative resection, transplantation, or ablative therapies. Tumors of mixed histology are not allowed.
  • Must have radiographically measurable disease in at least one site not previously treated with radiation, chemoembolization, radioembolization, or other local ablative procedures; a new area of tumor progression within or adjacent to a previously-treated lesion, if clearly measurable by a Radiologist, is acceptable.
  • May have received prior radiation, chemoembolization, radioembolization, or other local ablative therapies, or hepatic resection if completed ≥ 4 weeks prior to registration AND if patient has recovered to ≤ grade 1 toxicity. NOTE: Measurable disease (as required above) must still be present.
  • May have received prior radiation for bone or brain metastases if patient is now asymptomatic and has completed all radiation and steroid therapy (if applicable) ≥ 2 weeks prior to registration.
  • Age ≥ 18 years.
  • Child-Pugh score of A or B with ≤ 7 points.
  • Eastern Cooperative Oncology Group performance status of 0-1.
  • Willing to provide archived tissue, if available, from a previous diagnostic biopsy.
  • Must be able to tolerate CT and/or MRI with contrast.
  • Adequate organ function obtained ≤ 2 weeks prior to registration:

    • Absolute Neutrophil Count ≥ 1500/mm³
    • Hemoglobin ˃9.0 g/dL
    • Platelets ˃100,000/mm³
    • Serum Creatinine ≤ 1.5x Upper Limit Normal (ULN)
    • Creatinine Clearance ≥ 50 mL/min
    • Albumin ≥ 2.8 g/dL
    • Total Bilirubin ≤ 1.5 mg/dL or ≤ 1.5x ULN
    • Aspartate Aminotransaminase (AST)/Alanine Aminotransaminase (ALT) ≤ 2.5x ULN (≤ 5x ULN in patients with liver metastases)
    • International Normalized Ratio (INR) <1.5x the ULN [INR ≥ 1.5 is allowed if anticoagulation is used.]
  • Women must not be pregnant or breastfeeding since nab-paclitaxel and/or gemcitabine may harm the fetus or child.
  • Must not have received prior systemic cytotoxic chemotherapy or targeted therapy for this cancer.
  • Must not be receiving treatment with other investigational agents.
  • Must not have a pre-existing >grade 2 peripheral neuropathy.
  • Must not be receiving immunosuppressive medications, including systemic corticosteroids, aside from the following exceptions: used for adrenal replacement, appetite stimulation, therapy for asthma, bronchitis exacerbation (≤ 2 weeks), anti-emesis, or pre-medication for procedures (i.e. CT scan).
  • No known Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) seropositivity.
  • Must not have undergone liver transplantation.
  • Must not have serious non-healing wound, ulcer, bone fracture, or abscess.
  • Must not have undergone a major surgical procedure <4 weeks prior to registration.
  • Must not have possible histories of pneumonitis or pneumonitis risk factors.
  • Must not have an active second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ.
  • Must have no ongoing or active, uncontrolled infections.
  • Must have no evidence of significant, uncontrolled concomitant diseases including, but not limited to: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, myocardial infarction within preceding 12 months, uncontrolled peripheral vascular disease, cerebrovascular accident within preceding 12 months, pulmonary disease impairing functional status or requiring oxygen, connective tissue disease including lupus.
  • Must not have any history of allergic reaction(s) attributed to compounds of similar composition to nab-paclitaxel or gemcitabine.

Sites / Locations

  • Colorado Cancer Research Program
  • Northwestern University
  • Advocate Christ Medical Center
  • Siouxland Hematology-Oncology Associates
  • Ochsner Medical Center
  • Tufts Medical Center
  • University Massachusetts Memorial Medical Center
  • St. Joseph Mercy Health System
  • University of Michigan Health System
  • University of Michigan Medical Center
  • Metro Minnesota CCOP
  • Rutgers Cancer Institute of New Jersey
  • Montefiore Medical Center
  • Mount Sinai Hospital
  • University of Rochester Medical Center
  • University of Pennsylvania, Abramson Cancer Center
  • University of Pennsylvania; Abramson Cancer Center at Presbyterian Medical Center
  • Fox Chase Cancer Center
  • University of Tennessee Medical Center
  • Vanderbilt University/Ingram Cancer Center
  • University of Texas Southwestern Medical Center
  • Gundersen Health System
  • University of Wisconsin-Madison
  • Aurora Cancer Care
  • Medical University of Vienna

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nab-Paclitaxel and Gemcitabine

Arm Description

Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS) Rate at 6 Months (Proportion of Participants Alive and Progression-Free at 6 Months)
Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first. Progression-free survival rate at 6 months is defined as the proportion of patients who were disease progression-free and alive at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameter/axes of target lesions, taking as reference the smallest sum on study, or unequivocal progression of existing non-target lesions, or the appearance of new lesions.

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from enrollment until death or last patient contact.
Progression-free Survival (PFS)
Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first.
Time To Progression (TTP)
TTP was defined as the time from date of first dose of study therapy to date of removal from study for progression. Patients who have not experienced progression were censored at the date of last disease evaluation. Progression is evaluated using Solid Tumor Response Criteria (RECIST) Version 1.1. Progression is defined as at least a 20% increase in the sum of the diameters/axes of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm over the nadir. The appearance of new lesions or unequivocal progression of existing non-target lesions also constitutes disease progression.
Overall Response Rate (ORR)
Overall response rate is defined as the proportion of patients with complete response or partial response per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. A confirmation assessment performed >=4 weeks after the criteria for response is met is required.
Disease Control Rate (DCR)
Disease control rate is the proportion of patients achieved complete response, partial response or stable disease per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. Stable disease is defined as neither sufficient shrinkage to qualify for complete or partial response nor sufficient increase to qualify for progression. A confirmation assessment performed >=4 weeks after the criteria for response is met is required.
Association Between PFS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline
Patients were dichotomized into maximum CA 19-9 decline >=50% and maximum CA 19-9 decline <50%. Cox proportional hazards model was used to evaluate the association between PFS and maximum change in CA 19-9.
Association Between OS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline
Patients were dichotomized into maximum CA 19-9 decline >=50% and maximum CA 19-9 decline <50%. Cox proportional hazards model was used to evaluate the association between OS and maximum change in CA 19-9.

Full Information

First Posted
July 2, 2014
Last Updated
September 5, 2018
Sponsor
PrECOG, LLC.
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02181634
Brief Title
Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma
Acronym
PrE0204
Official Title
A Multi-Institutional, Single Arm, Two-Stage Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
December 9, 2014 (Actual)
Primary Completion Date
September 24, 2016 (Actual)
Study Completion Date
October 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PrECOG, LLC.
Collaborators
Celgene Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and gemcitabine chemotherapy. The purpose of this study is to evaluate the effectiveness and safety of the combination of nab-paclitaxel and gemcitabine. The effectiveness will be determined by improvement in the length of time during and after treatment, that the CCA does not get worse.
Detailed Description
Advanced cholangiocarcinomas (CCAs) are aggressive tumors with median survival time after diagnosis of less than 12 months, and five-year overall survival (OS) of ~5% with systemic chemotherapy. Currently available systemic therapies for CCA are largely ineffective, thus the rationale for the proposed research is to investigate targeted delivery of chemotherapy. The goal of this study is to evaluate the efficacy of gemcitabine plus nab-paclitaxel in patients with advanced CCA. This is based on the premise that nab-paclitaxel binds to SPARC (secreted protein acidic and rich in cysteine) through its interaction with albumin, leading to an increase in intra-tumoral concentration of gemcitabine through decreased deoxycytidine deaminase (CDA) enzyme. We hope to improve on the OS of patients with advanced CCA through the use of the synergistic combination of nab-paclitaxel and gemcitabine to specifically target the SPARC protein in the peri-tumoral stroma. We aim to provide critical data to further develop pharmacologic strategies to target the desmoplastic stroma in order to increase chemotherapy responsiveness of CCAs. We will also examine whether circulating tumor cell (CTC) levels with targeted gene expression analysis and stromal SPARC levels correlate with patient outcome and thus serve as prognostic biomarkers. We will evaluate the role of Human Equilibrative Nucleoside Transporter 1 (hENT1), CDA and tumor fibrosis as additional prognostic and predictive biomarkers in CCA. This clinical trial hopes to improve on the poor prognosis of patients with advanced CCA by establishing the activity of a platinum-free doublet, nab-paclitaxel plus gemcitabine that has shown clear clinical benefit in pancreatic cancer which has close biological parallels to CCA. A maximum of 70 patients will be enrolled to attain 67 eligible/evaluable patients. Stage I will enroll 37 patients. If 21 or more patients are alive and progression-free at 6 months, the study will proceed to Stage II and an additional 33 patients will be enrolled. Procurement of archived tissue, if available, from a previous diagnostic biopsy is mandatory for enrollment. If not available, this will not preclude participation in the trial, nor will additional biopsies be performed for research purposes only. Optional blood samples will be requested.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma
Keywords
Advanced Cholangiocarcinoma, Metastatic Cholangiocarcinoma, CCA, Bile Duct Cancer, Nab-Paclitaxel, Abraxane®, Gemcitabine, Gemzar®

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nab-Paclitaxel and Gemcitabine
Arm Type
Experimental
Arm Description
Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Nab-Paclitaxel and Gemcitabine
Other Intervention Name(s)
Abraxane®, Cytotoxic Antimicrotubular, Gemzar®, Pyrimidine Antimetabolite
Intervention Description
Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes.
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS) Rate at 6 Months (Proportion of Participants Alive and Progression-Free at 6 Months)
Description
Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first. Progression-free survival rate at 6 months is defined as the proportion of patients who were disease progression-free and alive at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameter/axes of target lesions, taking as reference the smallest sum on study, or unequivocal progression of existing non-target lesions, or the appearance of new lesions.
Time Frame
Assessed at 6 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from enrollment until death or last patient contact.
Time Frame
Every 3-6 months for up to 3 years
Title
Progression-free Survival (PFS)
Description
Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first.
Time Frame
Every 3-6 months for up to 3 years
Title
Time To Progression (TTP)
Description
TTP was defined as the time from date of first dose of study therapy to date of removal from study for progression. Patients who have not experienced progression were censored at the date of last disease evaluation. Progression is evaluated using Solid Tumor Response Criteria (RECIST) Version 1.1. Progression is defined as at least a 20% increase in the sum of the diameters/axes of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm over the nadir. The appearance of new lesions or unequivocal progression of existing non-target lesions also constitutes disease progression.
Time Frame
Every 3-6 months for up to 3 years
Title
Overall Response Rate (ORR)
Description
Overall response rate is defined as the proportion of patients with complete response or partial response per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. A confirmation assessment performed >=4 weeks after the criteria for response is met is required.
Time Frame
Every 3-6 months for up to 3 years
Title
Disease Control Rate (DCR)
Description
Disease control rate is the proportion of patients achieved complete response, partial response or stable disease per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. Stable disease is defined as neither sufficient shrinkage to qualify for complete or partial response nor sufficient increase to qualify for progression. A confirmation assessment performed >=4 weeks after the criteria for response is met is required.
Time Frame
Every 3-6 months for up to 3 years
Title
Association Between PFS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline
Description
Patients were dichotomized into maximum CA 19-9 decline >=50% and maximum CA 19-9 decline <50%. Cox proportional hazards model was used to evaluate the association between PFS and maximum change in CA 19-9.
Time Frame
CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment
Title
Association Between OS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline
Description
Patients were dichotomized into maximum CA 19-9 decline >=50% and maximum CA 19-9 decline <50%. Cox proportional hazards model was used to evaluate the association between OS and maximum change in CA 19-9.
Time Frame
CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment
Other Pre-specified Outcome Measures:
Title
Change in Circulating Tumor Cells (CTCs)
Description
Correlate change in CTCs to median PFS, OS, TTP, ORR and DCR.
Time Frame
Prior to Cycle 1, Day 1; Cycle 1 Day 8; Cycle 3, Day 1 and at Off Treatment
Title
Stromal SPARC Expression
Description
Correlate stromal SPARC (high versus low) expression by immunohistochemistry (IHC) with median PFS, OS, TTP, ORR and DCR.
Time Frame
Baseline
Title
Fibrosis Expression
Description
Correlate fibrosis (low, intermediate and high) by trichrome staining with median PFS, OS, TTP, ORR and DCR.
Time Frame
Baseline
Title
CDA Expression
Description
Correlate CDA (high versus low) expression by IHC with median PFS, OS, TTP, ORR and DCR.
Time Frame
Baseline
Title
hENT Expression
Description
Correlate hENT1 (high versus low) expression by IHC with median PFS, OS, TTP, ORR and DCR.
Time Frame
Baseline
Title
Banking Biospecimens for Future Assessment
Description
Optional specimen banking of patient blood specimens (including serum, plasma and buffy coat) as well as fixed left-over tissue specimens when available from all enrolled patients in this trial for possible future molecular, pharmacogenomic, and/or proteomic testing.
Time Frame
Prior to Cycle 1, Day 1; Cycle 1, Day 8; Cycle 3, Day 1 and at Off Treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have histologically-confirmed diagnosis of cholangiocarcinoma Stage II, III, or IV CCA (intra-hepatic, extra-hepatic and perihilar) that is not eligible for curative resection, transplantation, or ablative therapies. Tumors of mixed histology are not allowed. Must have radiographically measurable disease in at least one site not previously treated with radiation, chemoembolization, radioembolization, or other local ablative procedures; a new area of tumor progression within or adjacent to a previously-treated lesion, if clearly measurable by a Radiologist, is acceptable. May have received prior radiation, chemoembolization, radioembolization, or other local ablative therapies, or hepatic resection if completed ≥ 4 weeks prior to registration AND if patient has recovered to ≤ grade 1 toxicity. NOTE: Measurable disease (as required above) must still be present. May have received prior radiation for bone or brain metastases if patient is now asymptomatic and has completed all radiation and steroid therapy (if applicable) ≥ 2 weeks prior to registration. Age ≥ 18 years. Child-Pugh score of A or B with ≤ 7 points. Eastern Cooperative Oncology Group performance status of 0-1. Willing to provide archived tissue, if available, from a previous diagnostic biopsy. Must be able to tolerate CT and/or MRI with contrast. Adequate organ function obtained ≤ 2 weeks prior to registration: Absolute Neutrophil Count ≥ 1500/mm³ Hemoglobin ˃9.0 g/dL Platelets ˃100,000/mm³ Serum Creatinine ≤ 1.5x Upper Limit Normal (ULN) Creatinine Clearance ≥ 50 mL/min Albumin ≥ 2.8 g/dL Total Bilirubin ≤ 1.5 mg/dL or ≤ 1.5x ULN Aspartate Aminotransaminase (AST)/Alanine Aminotransaminase (ALT) ≤ 2.5x ULN (≤ 5x ULN in patients with liver metastases) International Normalized Ratio (INR) <1.5x the ULN [INR ≥ 1.5 is allowed if anticoagulation is used.] Women must not be pregnant or breastfeeding since nab-paclitaxel and/or gemcitabine may harm the fetus or child. Must not have received prior systemic cytotoxic chemotherapy or targeted therapy for this cancer. Must not be receiving treatment with other investigational agents. Must not have a pre-existing >grade 2 peripheral neuropathy. Must not be receiving immunosuppressive medications, including systemic corticosteroids, aside from the following exceptions: used for adrenal replacement, appetite stimulation, therapy for asthma, bronchitis exacerbation (≤ 2 weeks), anti-emesis, or pre-medication for procedures (i.e. CT scan). No known Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) seropositivity. Must not have undergone liver transplantation. Must not have serious non-healing wound, ulcer, bone fracture, or abscess. Must not have undergone a major surgical procedure <4 weeks prior to registration. Must not have possible histories of pneumonitis or pneumonitis risk factors. Must not have an active second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ. Must have no ongoing or active, uncontrolled infections. Must have no evidence of significant, uncontrolled concomitant diseases including, but not limited to: symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, myocardial infarction within preceding 12 months, uncontrolled peripheral vascular disease, cerebrovascular accident within preceding 12 months, pulmonary disease impairing functional status or requiring oxygen, connective tissue disease including lupus. Must not have any history of allergic reaction(s) attributed to compounds of similar composition to nab-paclitaxel or gemcitabine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vaibhav Sahai, MD
Organizational Affiliation
University of Michigan Health System in Ann Arbor, MI
Official's Role
Study Chair
Facility Information:
Facility Name
Colorado Cancer Research Program
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
St. Joseph Mercy Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Metro Minnesota CCOP
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of Pennsylvania, Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pennsylvania; Abramson Cancer Center at Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Gundersen Health System
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Aurora Cancer Care
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data is proprietary
Citations:
PubMed Identifier
30178032
Citation
Sahai V, Catalano PJ, Zalupski MM, Lubner SJ, Menge MR, Nimeiri HS, Munshi HG, Benson AB 3rd, O'Dwyer PJ. Nab-Paclitaxel and Gemcitabine as First-line Treatment of Advanced or Metastatic Cholangiocarcinoma: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):1707-1712. doi: 10.1001/jamaoncol.2018.3277.
Results Reference
result

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Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma

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