This trial is active, not recruiting.

Condition pancreatic cancer
Treatments fluorouracil, gemcitabine hydrochloride, irinotecan hydrochloride, leucovorin calcium, oxaliplatin
Phase phase 2/phase 3
Start date November 2004
Trial size 348 participants
Trial identifier NCT00112658, CDR0000430100, EU-20512, FRE-FNCLCC-ACCORD-11/0402


RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer.

PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Objective response rate (Phase II)
time frame:
Survival (Phase III)
time frame:

Secondary Outcomes

time frame:
Progression-free survival (Phase III)
time frame:
Quality of life (Phase III)
time frame:
Overall response rate (Phase III)
time frame:

Eligibility Criteria

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

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the pancreas - No other pancreatic tumor type, including either of the following: - Neuroendocrine tumor - Acinar cell tumor - Metastatic disease - Measurable disease in an area not previously irradiated - No cerebral metastases or meningeal involvement of the tumor PATIENT CHARACTERISTICS: Age - 18 to 75 Performance status - WHO 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,500/mm^3 - Platelet count ≥ 100,000/mm^3 Hepatic - Bilirubin ≤ 1.5 times upper limit of normal (biliary drainage allowed) Renal - Creatinine < 120 mmol/L Cardiovascular - No prior myocardial infarction - No prior angina - No uncompensated cardiac or coronary insufficiency - No symptomatic arrhythmia Gastrointestinal - No prior inflammatory bowel disease - No prior chronic diarrhea - No unresolved symptomatic occlusion or subocclusion of the bowel Other - Not pregnant or nursing - Fertile patients must use effective contraception - No ongoing active infection - No other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No contraindication to study treatment - No other serious medical disorder that would preclude study treatment - No psychiatric disorder or social or geographic situation that would preclude study participation - Not detained or under the guardianship of another person PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy Surgery - Not specified Other - No concurrent participation in another clinical trial using therapeutic experimental agents

Additional Information

Official title Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
Description OBJECTIVES: Primary - Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with oxaliplatin, irinotecan, leucovorin calcium, and fluorouracil vs gemcitabine as first-line chemotherapy. (Phase II) - Compare the survival of patients treated with these regimens. (Phase III) Secondary - Compare the toxicity of these regimens in these patients. - Compare progression-free survival of patients treated with these regimens. (Phase III) - Compare the overall response rate in patients treated with these regimens. (Phase III) - Compare quality of life of patients treated with these regimens. (Phase III) OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oxaliplatin IV over 2 hours, irinotecan IV over 1½ hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days. - Arm II: Patients receive gemcitabine IV on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 57, patients receive gemcitabine IV once weekly for 3 weeks (days 57, 64, and 71). Courses repeat every 28 days. PROJECTED ACCRUAL: A total of 348 patients (88 for phase II and 260 for phase III) will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in May 2011.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).