Gemcitabine and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, 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 whether giving both of these drugs on the same day is more effective than giving them on different days.

PURPOSE: This randomized phase III trial is studying two different schedules of gemcitabine and oxaliplatin to compare how well they work in treating patients with metastatic pancreatic cancer.

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

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Gemcitabine; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the pancreas

• Metastatic disease

• Measurable disease (primary tumor or metastasis)

• At least 1 cm in diameter by spiral CT scan

• No ampulla of Vater carcinoma or biliary adenocarcinoma

• No known brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%

• Life expectancy more than 12 weeks

• Absolute neutrophil count > 1,500/mm^3

• Platelet count > 100,000/mm^3

• Alkaline phosphatase < 5 times normal

• Bilirubin < 1.5 times normal

• Creatinine < 1.5 times normal

• No pre-existing neuropathy

• No unstable or uncontrolled pain

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No serious cardiovascular disease

• No serious respiratory disease

• No uncontrolled or persistent hypercalcemia

• No psychological, familial, social, or geographical condition that would preclude study treatment

• No other active malignancy

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy or radiotherapy

• No concurrent corticosteroids