Status:
COMPLETED
Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Lead Sponsor:
Federation Francophone de Cancerologie Digestive
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stoppin...
Detailed Description
OBJECTIVES: Primary * Compare the overall survival of patients with unresectable metastatic pancreatic cancer treated with fluorouracil, leucovorin calcium, and cisplatin followed by gemcitabine hyd...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas or ampulla
- Metastatic disease
- Unresectable disease
- Measurable disease, meeting the following criteria:
- No prior radiotherapy to the only site of measurable disease
- Diameter \> 10 mm by spiral CT scan or MRI OR \> 20 mm by conventional methods
- No brain metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy \> 2 months
- No contraindication to chemotherapy
- Creatinine clearance \> 60 mL/min
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Alkaline phosphatase \< 5 times normal
- Bilirubin ≤ 3 mg/dL
- No coronary insufficiency
- No symptomatic cardiac disease
- Good hydration possible
- No Child-Pugh class B or C cirrhosis
- No other malignancy except for basal cell skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior palliative or adjuvant chemotherapy
- At least 4 weeks since prior radiotherapy
- No radiotherapy during or for 4 weeks after study therapy
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00303758
Start Date
October 1 2005
End Date
March 1 2012
Last Update
March 4 2014
Active Locations (46)
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1
Centre Hospitalier d'Abbeville
Abbeville, France, 80101
2
Hopital Duffaut
Avignon, France, 84902
3
Centre Hospitalier de Blois
Blois, France, 41016
4
Centre Hospitalier Universitaire Ambroise Pare - Boulogne
Boulogne, France, F-92104