NCT00096070

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

Phase II Study of Oxaliplatin, Continuous 5-Fluorouracil and External Beam Radiation Followed by Gemcitabine in Patients With Locally Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Determine the 1-year survival rate in patients with locally advanced, unresectable adenocarcinoma of the pancreas treated with concurrent external beam radiotherapy, oxaliplatin, and fluorouracil followed by gemcitabine. SECONDARY OBJECTIVES: I. Determine overall survival, time to disease progression, and confirmed response rate in patients treated with this regimen. II. Determine toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients undergo radiotherapy once daily, 5 days a week, for 5.5 weeks. Beginning concurrently with radiotherapy, patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and fluorouracil IV continuously for 5.5 weeks. Beginning 4-6 weeks after the completion of chemoradiotherapy, patients receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment with gemcitabine repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

Conditions

• Adenocarcinoma of the Pancreas
• Stage II Pancreatic Cancer
• Stage III Pancreatic Cancer

Interventions

Type	Name	Description
RADIATION	radiation therapy	Undergo radiation therapy
DRUG	oxaliplatin	Given IV
DRUG	fluorouracil	Given IV
DRUG	gemcitabine hydrochloride	Given IV

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-04-01
• First posted: 2004-11-09
• Last updated: 2013-07-16

Locations

1 site across 1 country: United States