Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer

• Status: Completed
• Trial end date: 2010-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Calcium; Fluorouracil; Gemcitabine; Irinotecan; Leucovorin; Levoleucovorin; Oxaliplatin

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