Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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 stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.

PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Treatments: Calcium; Fluorouracil; Gemcitabine; Leucovorin; Levoleucovorin

Criteria

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