Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

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

Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

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

Details

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

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the pancreas

• Locally advanced, nonresectable disease

• Residual disease after surgical resection (R1, R2) OR recurrent disease after radical surgery

• No visceral or peritoneal metastases

• No adenocarcinoma of the bile ducts or the ampulla of Vater

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Stable or controlled pain with analgesics

• Not pregnant or nursing

• Neutrophil count ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Creatinine ≤ 1.5 times normal OR < 3 mg/dL

• Creatinine clearance ≥ 40 mL/min

• Bilirubin ≤ 1.5 times normal

• Alkaline phosphatase < 5 times normal

• No medical condition that would preclude study treatment

• No active infection

• Negative pregnancy test

• No serious cardiac or respiratory disease

• No uncontrolled or persistent hypercalcemia

• No pre-existing neuropathy

• No biliary or gastro-duodenal obstruction

• No other malignancy except nonmelanomatous skin cancer, prostate cancer, or carcinoma in situ of the cervix or bladder

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

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior abdominal radiotherapy (encompassing the liver, pancreas, or spleen)

• At least 2 months since prior radiotherapy