A Phase I Trial of Gemcitabine and Radiation in Locally Advanced Unresectable Cancer of the Pancreas

Phase 1

Completed

• Conditions: Gastrointestinal Neoplasms; Pancreatic Neoplasms

• Registration Number: NCT00001431
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Involved-field irradiation using 4-15 MV photons; plus Gemcitabine, NSC-613327.

Detailed Description

This is a Phase I trial of gemcitabine given weekly as a 30 minute infusion administered concurrently with radiation in patients with locally advanced or locally recurrent pancreatic carcinoma. Patients will be treated with external beam radiation therapy in a standard manner. Gemcitabine will be administered as a 30 minute infusion beginning on the first day of irradiation and weekly afterwards for a total of 5 doses. Patients will be assessed clinically for acute toxicity which will be graded per RTOG and DCT toxicity grading system.

Study Timeline

• Study Start: 1995-02
• Study First Submitted: 1999-11-03
• Status Verified: 2000-11
• Study Completion: 2000-11
• Study First Submitted QC: 2002-12-09
• Study First Posted: 2002-12-10
• Last Update Submitted: 2008-03-03
• Last Update Posted: 2008-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National Cancer Institute (NCI); 🇺🇸 Bethesda, Maryland, United States