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

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ClinicalTrials.gov Identifier: NCT00075452
Recruitment Status : Unknown
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2004
Last Update Posted : July 24, 2008
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.

PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.


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

Detailed Description:

OBJECTIVES:

Primary

  • Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin.

Secondary

  • Compare the time of response in patients treated with these regimens.
  • Compare the clinical benefit of and tolerance to these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the progression-free survival of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity.

After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy.

Quality of life is assessed at baseline and then every 2 months.

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
Study Start Date : November 2003





Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Time to response
  2. Clinical benefit
  3. Quality of life
  4. Progression-free survival


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed pancreatic adenocarcinoma

    • Locally advanced or metastatic disease
    • Unresectable disease
  • Measurable disease

    • At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner
  • No adenocarcinoma of the bile ducts or ampulla of Vater
  • No known brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 to 75

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 12 weeks

Hematopoietic

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic

  • Bilirubin less than 1.5 times normal
  • Alkaline phosphatase less than 5 times normal

Renal

  • Creatinine less than 1.5 times normal
  • No uncontrolled or persistent hypercalcemia

Cardiovascular

  • No serious cardiac failure

Pulmonary

  • No serious respiratory failure

Other

  • Pain must be stabilized or controlled before initiation of study treatment
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other untreatable malignant tumor
  • No serious psychological, familial, social, or geographical condition that would preclude study participation
  • No neuropathy that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • No concurrent corticosteroids except for antiemetic therapy

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified

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 ClinicalTrials.gov identifier (NCT number): NCT00075452


Locations
Show Show 38 study locations
Sponsors and Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
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OverallOfficial: Christophe Louvet, MD, PhD Hopital Saint Antoine
Publications of Results:
Other Publications:
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ClinicalTrials.gov Identifier: NCT00075452    
Other Study ID Numbers: CDR0000346480
FRE-GERCOR-GEM-GEMOX/D00-3
EU-20324
First Posted: January 12, 2004    Key Record Dates
Last Update Posted: July 24, 2008
Last Verified: May 2007
Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs