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

Completed · Phase 2

Conditions studied: Adenocarcinoma of the Pancreas, Stage II Pancreatic Cancer, Stage III Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT00096070

Run by

National Cancer Institute (NCI)

People needed

50

Starts

2004-12-01

Last updated by the study team

2013-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• North Central Cancer Treatment Group — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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