Radiotherapy Combined With Oxaliplatin and Fluorouracil Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer

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

Summary

This phase II trial is studying how well giving radiation therapy together with oxaliplatin and fluorouracil followed by gemcitabine works in treating patients with locally advanced, unresectable pancreatic cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Oxaliplatin may also make the tumor cells more sensitive to radiation therapy. Giving radiation therapy with chemotherapy may kill more tumor cells.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Fluorouracil; Gemcitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the pancreas

• Unresectable disease, including subtotal resection and gross residual disease

• Locally advanced disease

• No cystadenocarcinoma of the pancreas

• No pancreatic tumors of neuroendocrine origin

• No microscopic residual disease as only evidence of pancreatic cancer

• All disease must be encompassable within standard radiotherapy fields for pancreatic cancer

• No distant metastases (liver or lung metastases or peritoneal spread)

• No evidence of metastatic disease outside the planned radiotherapy field

• Performance status - ECOG 0-1

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

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9.0 g/dL

• Bilirubin ≤ 2 times upper limit of normal (ULN)

• AST ≤ 3 times ULN

• Creatinine ≤ 1.5 times ULN

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Able to maintain adequate oral nutrition

• No significant infection

• No significant nausea or vomiting

• No other medical condition that would preclude study participation

• No other malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score < 7)

• No known allergy to platinum compounds

• No prior biologic therapy

• No concurrent biologic therapy

• No concurrent immunotherapy

• No prior chemotherapy

• No other concurrent chemotherapy

• No prior radiotherapy that would overlap planned radiotherapy fields

• No other concurrent radiotherapy

• See Disease Characteristics

• At least 21 days since prior laparotomy