Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
18 Years
75 Years
Both
Pancreatic Cancer
Trial Information
Randomized Phase II/III Trial Comparing Folririnox Association [Oxaliplatin / Irinotecan / LV5FU2] Versus Gemcitabine in First Line of Chemotherapy in Metastatics Pancreas Cancers Patients
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Objective response rate (Phase II)
Safety Issue:
No
Principal Investigator
Thierry Conroy, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Alexis Vautrin
Authority:
United States: Federal Government
Study ID:
CDR0000430100
NCT ID:
NCT00112658
Start Date:
November 2004
Completion Date:
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
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