Bevacizumab, Erlotinib and Capecitabine for Advanced Pancreatic Cancer
The goal of this clinical research study is to find the highest tolerable dose of capecitabine, erlotinib hydrochloride, and bevacizumab that can be given in combination with radiation to patients with pancreatic cancer.
Radiation: Radiation Therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Preoperative Radiotherapy With Concurrent Bevacizumab, Erlotinib and Capecitabine for Locally Advanced Pancreatic Cancer|
- Highest Tolerated Dose of Capecitabine, Erlotinib Hydrochloride, and Bevacizumab + Radiation [ Time Frame: 5 1/2 Weeks ] [ Designated as safety issue: Yes ]
Any of these events considered a dose-limiting toxicity.
- Any grade 4 hemorrhage, grade 2 pulmonary or CNS hemorrhage
- Cardiac arrhythmia
- Grade 4 congestive heart failure
- Grade 4 hypertension or reversible posterior leukoencephalopathy syndrome (RPLS)
- Grade 4 nephrotic syndrome
- Grade 4 diarrhea
- Grade 4 rash
- Pulmonary adverse event related to erlotinib
- Bowel perforation
- Symptomatic Grade 4 venous thromboembolic event, or any grade arterial thromboembolic event
- Wound dehiscence requiring medical or surgical intervention
- Determination by the investigator that it is no longer safe for the subject to continue therapy
- Response Rate of Addition of Bevacizumab and Erlotinib to Capecitabine-Based Chemoradiation [ Time Frame: 4 to 6 weeks after radiation treatment ] [ Designated as safety issue: No ]Complete response (CR) — complete disappearance of clinical evidence of a tumor. Partial response (PR) — 50% or greater decrease in sum of products of the longest perpendicular diameters of all measured lesions compared to baseline. Stable disease (SD) — no significant change in disease status. Progressive disease (PD) — a 25% increase in the area of malignant lesions >2 cm2 or in sum of products of the longest perpendicular diameters of individual lesions in a given organ site. If only one lesion is available for measurement, a 50% increase in the size if the area of the lesion was 2 cm2. The appearance of new lesions will also constitute progressive disease. Comparisons of tumor size made with previous smallest measurement in patients who have attained a partial response or with baseline measurements in patients with stable disease. Tumor progression also defined as significant clinical deterioration that cannot be attributed to treatment or other medical conditions.
|Study Start Date:||January 2008|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Experimental: Bevacizumab, Erlotinib + Capecitabine
Bevacizumab intravenous (IV) every 2 weeks at 5 mg/kg, Erlotinib 100 mg orally (PO) daily + Capecitabine 400 mg/m2 PO twice daily (BID) only on days of radiation. Radiation treatment once daily for 5 1/2 weeks or 28 doses, Dose 50.4 Gy.
5 mg/kg IV Over 90 Minutes Every 2 Weeks
Other Names:Drug: Erlotinib
100 mg by mouth Once Daily on days with radiation.
Other Names:Drug: Capecitabine
400 mg/m^2 PO Twice Daily on days with radiation.
Other Name: XelodaRadiation: Radiation Therapy
Radiation treatment once daily for 5 1/2 weeks or 28 doses, Dose 50.4 Gy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00614653
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Sunil Krishnan, MD||M.D. Anderson Cancer Center|