A Trial of Chemo & Radiation Therapy for Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00424827|
Recruitment Status : Completed
First Posted : January 22, 2007
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine/Fluorouracil with External Beam Radiation||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Cetuximab, Gemcitabine, 5-Fluorouracil and Radiation Therapy in Locally Advanced Non-metastatic Pancreatic Adenocarcinoma|
|Study Start Date :||June 2006|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00424827
|Principal Investigator:||Venu Bathini, MD||University of Massachusetts, Worcester|