Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

• 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 tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.

PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.

• 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 pancreatic adenocarcinoma

• Locally advanced or metastatic disease

• Unresectable disease

• Measurable disease

• At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner

• No adenocarcinoma of the bile ducts or ampulla of Vater

• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 to 75

Performance status

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy

• More than 12 weeks

Hematopoietic

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count greater than 100,000/mm^3

Hepatic

• Bilirubin less than 1.5 times normal

• Alkaline phosphatase less than 5 times normal

Renal

• Creatinine less than 1.5 times normal

• No uncontrolled or persistent hypercalcemia

Cardiovascular

• No serious cardiac failure

Pulmonary

• No serious respiratory failure

Other

• Pain must be stabilized or controlled before initiation of study treatment

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other untreatable malignant tumor

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

• No neuropathy that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• No concurrent corticosteroids except for antiemetic therapy

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified