A Trial of Chemo & Radiation Therapy for Pancreatic Cancer
|Pancreatic Cancer||Drug: Gemcitabine/Fluorouracil with External Beam Radiation||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-metastatic Pancreatic Adenocarcinoma|
- Progression-free Survival of Patients With Locally Advanced Pancreatic Cancer Treated With Concurrent Gemcitabine, 5-FU, Cetuximab and External Beam Radiation Therapy. [ Time Frame: 1-year ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Biomarker Response to Chemoradiation Therapy [ Time Frame: 1-year ]20% decrease in biomarker (CA19-9) from baseline
- Resection Rate [ Time Frame: 1-Year ]
- Overall Survival [ Time Frame: Up to 2 years ]
- Toxicity Associated With This Regimen. [ Time Frame: 1-Year ]
|Study Start Date:||June 2006|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine/Fluorouracil with External Beam Radiation
This protocol will assess the antitumor activity of Gemcitabine/Fluorouracil with External Beam Radiation in patients with non-metastatic, locally advanced pancreatic carcinoma.
Drug: Gemcitabine/Fluorouracil with External Beam Radiation
This protocol will assess the antitumor activity of gemcitabine (200 mg/m2 per week) and cetuximab (400mg/m2 loading dose followed by 250 mg/m2 weekly) when given with continuous infusion 5-FU (200 mg/m2/day/M-F) and daily concurrent external beam radiation therapy (50.4 Gy) in patients with non-metastatic, locally advanced pancreatic carcinoma.
Other Name: EGFR Expression; Cetuximab & Radiosensitization of Cetuximab
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424827
|Principal Investigator:||Venu Bathini, MD||University of Massachusetts, Worcester|