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Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
interferon-alfa-2b
cisplatin
5-fluorouracil
radiation therapy
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas

Eligibility Criteria

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

Inclusion Criteria: Patient must be > 18 years of age. Patient must have a documented ECOG/Zubrod performance status of 0 or 1, within 7 days prior to registration. Patient must have pathological stage T1-3, N0-1, M0 adenocarcinoma of the head of the pancreas according to the American Joint Committee on Cancer (AJCC) staging system. NOTE: The pathology report must be submitted to ACOSOG on the Pathology Report Shuttle CRF. Patient must have undergone a potentially curative gross total resection by pancreaticoduodenectomy (includes R0 [no residual tumor] or R1 [microscopic residual tumor]) within 56 days prior to beginning treatment. NOTE: The operative report must be submitted to ACOSOG on the Operative Report Shuttle CRF. Patient must have stable or increasing weight in the 14 days prior to the start of treatment, otherwise supplemental nutrition (e.g. feeding jejunostomy, PEG, TPN) must be initiated prior to the start of treatment.6. Patient must have adequate bone marrow, hepatic and renal function, within 7 days prior to registration: WBC > 3,000 mm^3 ANC > 1,500 mm^3 hemoglobin > 9.5 mg/dl platelet count > 100,000 mm^3 total bilirubin < 3 mg/dl AST (SGOT) < 2.0 times institutional upper limit of normal (ULN) ALT (SGPT) < 2.0 times institutional ULN alkaline phosphatase < 2.0 times institutional ULN serum creatinine < 1.5 times institutional ULN 7. Patient must have a baseline diagnostic CT scan of the chest and CT scan with IV contrast (or MRI) of abdomen/pelvis, within 30 days prior to registration, to exclude metastatic disease. 8. If female of childbearing potential, patient must have a negative urine or serum pregnancy test, within 7 days prior to registration. NOTE: Postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered not of childbearing potential. 9. Patient (male or female) of reproductive potential must agree to use medically acceptable contraception during the study. NOTE: Medically acceptable contraceptives include: (1) surgical sterilization, (2) approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). 10. Patient, or the patient's legally acceptable representative, must sign and date an informed consent PRIOR to registration and the performance of any study related procedures. 11. Patient, or the patient's legally acceptable representative, must provide written authorization to allow the use and disclosure of their protected health information. - NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration. 12. If patient is a cancer survivor, all of the following criteria must be met and documented in the patient's medical record: Patient has undergone potentially curative therapy for all prior malignancies. No evidence of prior malignancies for at least 5 years (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or nonmelanoma skin cancer). No evidence of recurrence of any prior malignancy. Exclusion Criteria: Patient has pancreaticoduodenectomy histopathology of adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma. Patient is pregnant or lactating. Patient has recurrent pancreatic cancer. Patient has received prior systemic chemotherapy or radiotherapy for pancreatic cancer. Patient has received external beam photon (x-ray) therapy to the chest, abdomen or pelvis. Patient has received any biologic/ immunologic therapies. Patient has received chronic immunotherapy (e.g. prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality. Patient has a preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorders.

Sites / Locations

  • University of Florida Shands Cancer Center
  • Rush University Medical Center
  • James Graham Brown Cancer Center at University of Louisville
  • Massachusetts General Hospital Cancer Center
  • Brigham and Women's Hospital
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Fairview University Medical Center - University Campus
  • Roswell Park Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Vanderbilt-Ingram Cancer Center
  • Presbyterian Hospital of Dallas
  • Baylor University Medical Center - Houston
  • Medical College of Wisconsin Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interferon-based chemoradiation therapy

Arm Description

Cycle 1: Chemoradiotherapy (CRT) 5-fluorouracil continuous infusion (CI) via an ambulatory infusion pump into a central venous catheter at 175 mg/m2/day for 38 consecutive days, unless toxicity occurs cisplatin given on the first day only of each week of this cycle (days 1, 8, 15, 22, 29, 36) IFN-alpha-2b 3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks XRT 5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday - Friday, for 5½ weeks Cycles 2 and 3: Post-CRT Chemotherapy Post-CRT chemotherapy starts 4 - 6 weeks after completion of Cycle 1, unless the study physician deems further delay is necessary. Patients will be given 2 cycles of chemotherapy (cycles 2 and 3). -- 5-fluorouracil continuous infusion via an ambulatory infusion pump into a central venous catheter at 200 mg/m2/day for 6 weeks followed by 2 weeks of rest

Outcomes

Primary Outcome Measures

Overall survival at 18 months

Secondary Outcome Measures

Toxicity
Disease-free survival
Local-regional disease control
Distant disease control

Full Information

First Posted
May 6, 2003
Last Updated
December 5, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00059826
Brief Title
Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer
Official Title
A Phase II Study of Interferon-Based Adjuvant Chemoradiation in Patients With Resected Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Radiation therapy uses high-energy radiation from x-rays and other sources to kill tumor cells. Combining chemotherapy with interferon alfa and giving them with radiation therapy after surgery may kill any remaining tumor cells. PURPOSE: Phase II trial to study the effectiveness of adjuvant chemoradiotherapy and interferon alfa in treating patients who have resected stage I, stage II, or stage III pancreatic cancer.
Detailed Description
OBJECTIVES: Determine the disease-free and overall survival of patients with resected pancreatic adenocarcinoma treated with adjuvant chemoradiotherapy comprising fluorouracil, cisplatin, and interferon alfa. Determine the rate and severity of acute and late toxic effects in patients treated with this regimen. Determine the local-regional disease control and distant disease control in patients treated with this regimen. OUTLINE: This is a multicenter study. Chemoradiotherapy (CRT): Patients receive fluorouracil IV continuously on days 1-38; cisplatin IV over 1 hour on days 1, 8, 15, 22, 29, and 36; and interferon alfa subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, and 38. Patients also undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38. Post-CRT chemotherapy: Beginning 4-6 weeks after the completion of CRT, patients receive fluorouracil IV continuously on days 1-42. Treatment repeats every 56 days for a total of two courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, adenocarcinoma of the pancreas

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Interferon-based chemoradiation therapy
Arm Type
Experimental
Arm Description
Cycle 1: Chemoradiotherapy (CRT) 5-fluorouracil continuous infusion (CI) via an ambulatory infusion pump into a central venous catheter at 175 mg/m2/day for 38 consecutive days, unless toxicity occurs cisplatin given on the first day only of each week of this cycle (days 1, 8, 15, 22, 29, 36) IFN-alpha-2b 3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks XRT 5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday - Friday, for 5½ weeks Cycles 2 and 3: Post-CRT Chemotherapy Post-CRT chemotherapy starts 4 - 6 weeks after completion of Cycle 1, unless the study physician deems further delay is necessary. Patients will be given 2 cycles of chemotherapy (cycles 2 and 3). -- 5-fluorouracil continuous infusion via an ambulatory infusion pump into a central venous catheter at 200 mg/m2/day for 6 weeks followed by 2 weeks of rest
Intervention Type
Biological
Intervention Name(s)
interferon-alfa-2b
Other Intervention Name(s)
IFN-alpha-2b
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
IV
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
XRT
Primary Outcome Measure Information:
Title
Overall survival at 18 months
Time Frame
at 18 months
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
at 18 months
Title
Disease-free survival
Time Frame
at 18 months
Title
Local-regional disease control
Time Frame
at 18 months
Title
Distant disease control
Time Frame
at 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must be > 18 years of age. Patient must have a documented ECOG/Zubrod performance status of 0 or 1, within 7 days prior to registration. Patient must have pathological stage T1-3, N0-1, M0 adenocarcinoma of the head of the pancreas according to the American Joint Committee on Cancer (AJCC) staging system. NOTE: The pathology report must be submitted to ACOSOG on the Pathology Report Shuttle CRF. Patient must have undergone a potentially curative gross total resection by pancreaticoduodenectomy (includes R0 [no residual tumor] or R1 [microscopic residual tumor]) within 56 days prior to beginning treatment. NOTE: The operative report must be submitted to ACOSOG on the Operative Report Shuttle CRF. Patient must have stable or increasing weight in the 14 days prior to the start of treatment, otherwise supplemental nutrition (e.g. feeding jejunostomy, PEG, TPN) must be initiated prior to the start of treatment.6. Patient must have adequate bone marrow, hepatic and renal function, within 7 days prior to registration: WBC > 3,000 mm^3 ANC > 1,500 mm^3 hemoglobin > 9.5 mg/dl platelet count > 100,000 mm^3 total bilirubin < 3 mg/dl AST (SGOT) < 2.0 times institutional upper limit of normal (ULN) ALT (SGPT) < 2.0 times institutional ULN alkaline phosphatase < 2.0 times institutional ULN serum creatinine < 1.5 times institutional ULN 7. Patient must have a baseline diagnostic CT scan of the chest and CT scan with IV contrast (or MRI) of abdomen/pelvis, within 30 days prior to registration, to exclude metastatic disease. 8. If female of childbearing potential, patient must have a negative urine or serum pregnancy test, within 7 days prior to registration. NOTE: Postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered not of childbearing potential. 9. Patient (male or female) of reproductive potential must agree to use medically acceptable contraception during the study. NOTE: Medically acceptable contraceptives include: (1) surgical sterilization, (2) approved hormonal contraceptives (such as birth control pills, Depo-Provera, or Lupron Depot), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). 10. Patient, or the patient's legally acceptable representative, must sign and date an informed consent PRIOR to registration and the performance of any study related procedures. 11. Patient, or the patient's legally acceptable representative, must provide written authorization to allow the use and disclosure of their protected health information. - NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration. 12. If patient is a cancer survivor, all of the following criteria must be met and documented in the patient's medical record: Patient has undergone potentially curative therapy for all prior malignancies. No evidence of prior malignancies for at least 5 years (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or nonmelanoma skin cancer). No evidence of recurrence of any prior malignancy. Exclusion Criteria: Patient has pancreaticoduodenectomy histopathology of adenosquamous carcinoma, ampullary carcinoma, carcinoid tumor, cystadenocarcinoma, cystadenoma, distal common bile duct carcinoma, duodenal carcinoma, or islet cell carcinoma. Patient is pregnant or lactating. Patient has recurrent pancreatic cancer. Patient has received prior systemic chemotherapy or radiotherapy for pancreatic cancer. Patient has received external beam photon (x-ray) therapy to the chest, abdomen or pelvis. Patient has received any biologic/ immunologic therapies. Patient has received chronic immunotherapy (e.g. prednisone or methotrexate) for collagen vascular disease or other chronic immunologic abnormality. Patient has a preexisting psychiatric condition, especially depression, or a history of severe psychiatric disorders.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent J. Picozzi, MD
Organizational Affiliation
Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0232
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
James Graham Brown Cancer Center at University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Fairview University Medical Center - University Campus
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Presbyterian Hospital of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor University Medical Center - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20670978
Citation
Picozzi VJ, Abrams RA, Decker PA, Traverso W, O'Reilly EM, Greeno E, Martin RC, Wilfong LS, Rothenberg ML, Posner MC, Pisters PW; American College of Surgeons Oncology Group. Multicenter phase II trial of adjuvant therapy for resected pancreatic cancer using cisplatin, 5-fluorouracil, and interferon-alfa-2b-based chemoradiation: ACOSOG Trial Z05031. Ann Oncol. 2011 Feb;22(2):348-54. doi: 10.1093/annonc/mdq384. Epub 2010 Jul 29.
Results Reference
result
Citation
Picozzi VJ, Abrams RA, Traverso LW, et al.: ACOSOG Z05031: initial report of a multicenter, phase II trial of a novel chemoradiation protocol using cisplatin, 5-FU, and alpha- interferon as adjuvant therapy for resected pancreas cancer. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-125, 2008.
Results Reference
result
Citation
Picozzi VJ, Abrams RA, Traverso LW, et al.: ACOSOG Z05031: report on a multicenter, phase II trial for adjuvant therapy of resected pancreatic cancer using cisplatin, 5- FU, and alpha-interferon. [Abstract] J Clin Oncol 26 (Suppl 15): A-4505, 2008.
Results Reference
result

Learn more about this trial

Adjuvant Chemoradiotherapy and Interferon Alfa in Treating Patients With Resected Pancreatic Cancer

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