Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	18 and over	NCI	ECOG-6201 E6201, NCT00058149

Special Category: CTSU trial

Objectives

1. Compare survival of patients with locally advanced or metastatic pancreatic cancer treated with prolonged infusion gemcitabine with vs without oxaliplatin vs standard infusion gemcitabine.
2. Compare the toxicity of these regimens in these patients.
3. Compare the objective response in patients treated with these regimens.
4. Compare the patterns of failure and progression-free survival of patients treated with these regimens.
5. Compare the reported frequency of deep vein thrombosis and pulmonary embolism among patients treated with these regimens.
6. Compare the changes in quality of life, including improved symptom control and/or additional side effects of patients treated with these regimens.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,500/mm³

  OR

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 125,000/mm³

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

Expected Enrollment

A total of 789 patients (263 per treatment arm) will be accrued for this study within 18 months.

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.

Poplin E, Feng Y, Berlin J, et al.: 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 27 (23): 3778-85, 2009.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Eastern Cooperative Oncology Group

Elizabeth Poplin, MD, Protocol chair		Ph: 732-235-6777

Registry Information
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
Trial Start Date		2003-03-26
Trial Completion Date		2006-07-11
Registered in ClinicalTrials.gov		NCT00058149
Date Submitted to PDQ		2003-02-19
Information Last Verified		2004-04-30
NCI Grant/Contract Number		CA21115

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