Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma
Data Collection
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: November 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 38 locations
C.H.G. Beauvais
Beauvais, FranceHopital Saint Andre
Bordeaux, FranceCHU Ambroise Pare
Boulogne-Billancourt, France