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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00058149
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : September 21, 2011
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: gemcitabine hydrochloride Drug: oxaliplatin Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
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 Start Date : March 2003
Actual Primary Completion Date : July 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Performance status

  • ECOG 0-2

Life expectancy

  • 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


Biologic therapy

  • 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

Endocrine therapy

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00058149

Show Show 61 study locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: Elizabeth A. Poplin, MD Rutgers Cancer Institute of New Jersey
Publications of Results:
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.

Layout table for additonal information Identifier: NCT00058149    
Other Study ID Numbers: CDR0000287015
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: September 21, 2011
Last Verified: April 2004
Keywords provided by National Cancer Institute (NCI):
stage II pancreatic cancer
stage III pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs