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A Trial of Chemo & Radiation Therapy for Pancreatic Cancer

2014-08-27 03:40:34 | BioPortfolio

Summary

To assess progression-free survival of patients with locally advanced pancreatic cancer who are treated with concurrent gemcitabine, 5-FU, cetuximab and external beam radiation therapy.

Description

This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU, and external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic cancer.

All patients will be assessed by history and physical examination including weight, vital signs, and performance status within 14 days of initiation of therapy. Baseline hematologic and biochemical profiles, including CBC with differential, alkaline phosphatase, bilirubin, SGOT (AST), BUN, creatinine, and CA 19-9 will be completed within 14 days of initiation of therapy.

During cycle I (chemoradiation), gemcitabine (200 mg/m2) and cetuximab 400mg/m2 initial dose followed by 250mg/m2 IV weekly will be given with continuous infusion 5-FU (200 mg/m2/day) delivered 5 of every 7 days and concurrent external beam radiation therapy. Cetuximab, gemcitabine and 5-FU will begin on the first week of external beam radiotherapy and will continue throughout the course of external beam radiation therapy, and will be discontinued following the conclusion of external beam radiation therapy. All patients will have a central venous access device placed to facilitate chemotherapy administration.

During cycles 2 through 5 (chemotherapy), gemcitabine will be administered at a dose of 1000 mg/m2 over 30 minutes followed by cetuximab at a dose of 250mg/m2 over 30 minutes weekly for 3 weeks followed by one-week rest for four cycles.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pancreatic Cancer

Intervention

Gemcitabine/Fluorouracil with External Beam Radiation

Location

University of Massachusetts Medical School
Worcester
Massachusetts
United States
01655-0002

Status

Recruiting

Source

University of Massachusetts, Worcester

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:34-0400

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