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Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
gemcitabine hydrochloride
oxaliplatin
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma or poorly differentiated carcinoma Ineligible for curative resection Measurable and/or nonmeasurable disease Must have evidence of disease outside prior radiation fields OR radiologically confirmed progression of disease within the radiation fields after completion of radiotherapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic WBC ≥ 3,500/mm^3 OR Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 125,000/mm^3 Hepatic Bilirubin < 2.0 mg/dL AST < 3 times upper limit of normal (ULN) Renal Creatinine ≤ 1.5 times ULN Cardiovascular No uncontrolled cardiac disease Other Not pregnant or nursing Negative pregnancy test Negative vaginal ultrasound for patients with an elevated beta human chorionic gonadotropin level Fertile patients must use effective nonhormonal contraception No other malignancies within the past 5 years except nonmetastatic, nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy No active or uncontrolled infection No other active illness that would preclude study participation No symptomatic sensory peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic disease No prior (including adjuvant) gemcitabine or oxaliplatin Prior adjuvant chemotherapy allowed provided there was more than 6 months between the last dose of adjuvant chemotherapy and recurrence of pancreatic cancer Prior chemotherapy as a radiosensitizing agent allowed* NOTE: *To the primary site Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy to the primary tumor site and recovered No prior radiotherapy to more than 25% of the functional bone marrow Surgery See Disease Characteristics Prior surgical resection allowed Other No concurrent participation in supportive care trials Concurrent enrollment on protocol ECOG-E1Y03 allowed

Sites / Locations

  • Comprehensive Cancer Institute
  • CCOP - Mayo Clinic Scottsdale Oncology Program
  • Medical Center of Aurora - South Campus
  • Boulder Community Hospital
  • Penrose Cancer Center at Penrose Hospital
  • Porter Adventist Hospital
  • St. Joseph Hospital
  • Presbyterian - St. Luke's Medical Center
  • Rocky Mountain Cancer Centers - Denver Rose
  • CCOP - Colorado Cancer Research Program, Incorporated
  • Swedish Medical Center
  • Sky Ridge Medical Center
  • Hope Cancer Care Center at Longmont United Hospital
  • St. Mary-Corwin Regional Medical Center
  • Rocky Mountain Cancer Centers - Thornton
  • Winship Cancer Institute of Emory University
  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • Veterans Affairs Medical Center - Lakeside Chicago
  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • CCOP - Central Illinois
  • Decatur Memorial Hospital Cancer Care Institute
  • Hinsdale Hematology Oncology Associates
  • La Grange Oncology Associates
  • Swedish-American Regional Cancer Center
  • CCOP - Carle Cancer Center
  • Indiana University Cancer Center
  • Veterans Affairs Medical Center - Indianapolis (Roudebush)
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • CCOP - Wichita
  • Veterans Affairs Medical Center - Wichita
  • MBCCOP - LSU Health Sciences Center
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • Cancer Center at Tufts - New England Medical Center
  • Beth Israel Deaconess Medical Center
  • West Michigan Cancer Center
  • Mayo Clinic Cancer Center
  • CCOP - Metro-Minnesota
  • CCOP - Southern Nevada Cancer Research Foundation
  • Veterans Affairs Medical Center - East Orange
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • MBCCOP - University of New Mexico HSC
  • Albert Einstein Cancer Center at Albert Einstein College of Medicine
  • NYU Cancer Institute at New York University Medical Center
  • CCOP - Merit Care Hospital
  • MetroHealth's Cancer Care Center at MetroHealth Medical Center
  • CCOP - Columbus
  • CCOP - Oklahoma
  • CCOP - Geisinger Clinic and Medical Center
  • Abramson Cancer Center at the University of Pennsylvania
  • Fox Chase Cancer Center
  • Hillman Cancer Center at University of Pittsburgh Cancer Institute
  • CCOP - MainLine Health
  • Lankenau Cancer Center at Lankenau Hospital
  • CCOP - Sioux Community Cancer Consortium
  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
  • CCOP - Scott and White Hospital
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
  • University of Wisconsin Comprehensive Cancer Center
  • CCOP - Marshfield Clinic Research Foundation
  • Pretoria Academic Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2003
Last Updated
September 20, 2011
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00058149
Brief Title
Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Official Title
A Phase III, Randomized Study of Gemcitabine (Fixed-Dose Rate Infusion) and Oxaliplatin (NSC 266046) Versus Gemcitabine (Fixed-Dose Rate Infusion) Versus Gemcitabine (30-Minute Infusion) in Pancreatic Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2004
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy such as gemcitabine and oxaliplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways may kill more tumor cells. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without oxaliplatin in treating patients who have locally advanced or metastatic pancreatic cancer.
Detailed Description
OBJECTIVES: Compare survival of patients with locally advanced or metastatic pancreatic cancer treated with prolonged infusion gemcitabine with vs without oxaliplatin vs standard infusion gemcitabine. Compare the toxicity of these regimens in these patients. Compare the objective response in patients treated with these regimens. Compare the patterns of failure and progression-free survival of patients treated with these regimens. Compare the reported frequency of deep vein thrombosis and pulmonary embolism among patients treated with these regimens. Compare the changes in quality of life, including improved symptom control and/or additional side effects of patients treated with these regimens. OUTLINE: This is a multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2) and disease stage (locally advanced vs metastatic). Patients are randomized to 1 of 3 treatment arms. Arm I (standard treatment): Patients receive gemcitabine IV over 30 minutes once weekly for 7 weeks followed by 1 week of rest for course 1 only. In all subsequent courses, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, with courses repeating every 4 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive gemcitabine IV over 150 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Arm III: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 120 minutes on day 2. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then at 8 and 16 weeks. Patients are followed for 3 years. PROJECTED ACCRUAL: A total of 789 patients (263 per treatment arm) will be accrued for this study within 18 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
oxaliplatin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced or metastatic pancreatic adenocarcinoma or poorly differentiated carcinoma Ineligible for curative resection Measurable and/or nonmeasurable disease Must have evidence of disease outside prior radiation fields OR radiologically confirmed progression of disease within the radiation fields after completion of radiotherapy PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic WBC ≥ 3,500/mm^3 OR Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 125,000/mm^3 Hepatic Bilirubin < 2.0 mg/dL AST < 3 times upper limit of normal (ULN) Renal Creatinine ≤ 1.5 times ULN Cardiovascular No uncontrolled cardiac disease Other Not pregnant or nursing Negative pregnancy test Negative vaginal ultrasound for patients with an elevated beta human chorionic gonadotropin level Fertile patients must use effective nonhormonal contraception No other malignancies within the past 5 years except nonmetastatic, nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy No active or uncontrolled infection No other active illness that would preclude study participation No symptomatic sensory peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic disease No prior (including adjuvant) gemcitabine or oxaliplatin Prior adjuvant chemotherapy allowed provided there was more than 6 months between the last dose of adjuvant chemotherapy and recurrence of pancreatic cancer Prior chemotherapy as a radiosensitizing agent allowed* NOTE: *To the primary site Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy to the primary tumor site and recovered No prior radiotherapy to more than 25% of the functional bone marrow Surgery See Disease Characteristics Prior surgical resection allowed Other No concurrent participation in supportive care trials Concurrent enrollment on protocol ECOG-E1Y03 allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A. Poplin, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Institute
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
CCOP - Mayo Clinic Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
Medical Center of Aurora - South Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012-0000
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301-9019
Country
United States
Facility Name
Penrose Cancer Center at Penrose Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80933
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
St. Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218-1191
Country
United States
Facility Name
Presbyterian - St. Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Denver Rose
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
CCOP - Colorado Cancer Research Program, Incorporated
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Hope Cancer Care Center at Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
St. Mary-Corwin Regional Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
Rocky Mountain Cancer Centers - Thornton
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Veterans Affairs Medical Center - Atlanta (Decatur)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Veterans Affairs Medical Center - Lakeside Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-4494
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Hinsdale Hematology Oncology Associates
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
La Grange Oncology Associates
City
La Grange
State/Province
Illinois
ZIP/Postal Code
60525
Country
United States
Facility Name
Swedish-American Regional Cancer Center
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61104-2315
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
Veterans Affairs Medical Center - Indianapolis (Roudebush)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
Veterans Affairs Medical Center - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67218
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Cancer Center at Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
CCOP - Southern Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Veterans Affairs Medical Center - East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
MBCCOP - University of New Mexico HSC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Albert Einstein Cancer Center at Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
NYU Cancer Institute at New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
CCOP - Merit Care Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
MetroHealth's Cancer Care Center at MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43206
Country
United States
Facility Name
CCOP - Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
CCOP - Geisinger Clinic and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
Abramson Cancer Center at the University of Pennsylvania
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
19111-2497
Country
United States
Facility Name
Hillman Cancer Center at University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
CCOP - MainLine Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Lankenau Cancer Center at Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6307
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
CCOP - St. Vincent Hospital Cancer Center, Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Pretoria Academic Hospital
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa

12. IPD Sharing Statement

Citations:
PubMed Identifier
19581537
Citation
Poplin E, Feng Y, Berlin J, Rothenberg ML, Hochster H, Mitchell E, Alberts S, O'Dwyer P, Haller D, Catalano P, Cella D, Benson AB 3rd. Phase III, randomized study of gemcitabine and oxaliplatin versus gemcitabine (fixed-dose rate infusion) compared with gemcitabine (30-minute infusion) in patients with pancreatic carcinoma E6201: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009 Aug 10;27(23):3778-85. doi: 10.1200/JCO.2008.20.9007. Epub 2009 Jul 6. Erratum In: J Clin Oncol. 2009 Dec 1;27(34):5859.
Results Reference
result
Citation
Liebes L, Levy DE, Poplin E, et al.: Gemcitabine (G) plasma and intracellular pharmacokinetics in E6201: greater metabolite levels using fixed dosing rate (FDR) delivery. [Abstract] J Clin Oncol 24 (Suppl 18): A-2024, 2006.
Results Reference
result
Citation
Poplin E, Levy DE, Berlin J, et al.: Phase III trial of gemcitabine (30-minute infusion) versus gemcitabine (fixed-dose-rate infusion[FDR]) versus gemcitabine + oxaliplatin(GEMOX) in patients with advanced pancreatic cancer (E6201). [Abstract] J Clin Oncol 24 (Suppl 18): A-LBA4004, 180s, 2006.
Results Reference
result

Learn more about this trial

Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer

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