Gemcitabine With Or Without Oxaliplatin In Treating Patients With Locally Advanced Or Metastatic Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Cancer

DRUG: gemcitabine hydrochloride
DRUG: oxaliplatin

CDR0000287015
ECOG-6201

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2003-04-07	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2011-09-20
First Submitted that Met QC Criteria 2003-04-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-09-21
First Posted (ESTIMATED) 2003-04-09	Results First Posted N/A	Last Verified 2004-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

18 and over

ECOG 0-2

Not specified

WBC ≥ 3,500/mm^3 OR
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 125,000/mm^3

Bilirubin < 2.0 mg/dL
AST < 3 times upper limit of normal (ULN)

Creatinine ≤ 1.5 times ULN

No uncontrolled cardiac disease

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

Not specified

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

Not specified

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

See Disease Characteristics
Prior surgical resection allowed

No concurrent participation in supportive care trials
Concurrent enrollment on protocol ECOG-E1Y03 allowed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Elizabeth A. Poplin, MD, Rutgers Cancer Institute of New Jersey

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
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.
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.

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