Overview

This trial is active, not recruiting.

Condition pancreatic cancer
Treatments gemcitabine hydrochloride, oxaliplatin
Phase phase 3
Sponsor Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Start date November 2003
Trial identifier NCT00075452, CDR0000346480, EU-20324, FRE-GERCOR-GEM-GEMOX/D00-3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Measure
Overall survival
time frame:

Secondary Outcomes

Measure
Time to response
time frame:
Clinical benefit
time frame:
Quality of life
time frame:
Progression-free survival
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).