Status:
WITHDRAWN
Efficacy Study of Gemcitabine, Paclitaxel, and Irradiation in the Treatment of Pancreatic Cancer
Lead Sponsor:
New York Presbyterian Brooklyn Methodist Hospital
Conditions:
Carcinoma, Pancreatic Ductal
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to find out what effects, good and bad, the chemotherapy drugs gemcitabine (Gemzar) and paclitaxel (Taxol) have in combination with twice daily radiation treatment on loca...
Detailed Description
Based on our previous experience with the use of a weekly paclitaxel dose of 60 mg/m2 and hyperfractionated radiation therapy 63.8 Gy, we are conducting this study incorporating the use of Gemcitabine...
Eligibility Criteria
Inclusion
- Pathologically confirmed adenocarcinoma of the pancreas.
- Patients must have locally advanced/unresectable disease based on institutional standardized criteria of unresectability.
- Patients with residual disease after resection (R-1 or -2, micro and macroscopic residual) are eligible.
- Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation.
- All malignant disease must be encompassed within a single irradiation field (12 x 12 cm maximum).
- All patients must have radiographically assessable disease.
- Electrocardiogram (EKG), chest x-ray, abdominal computed tomography (CT)/magnetic resonance imaging (MRI) scan must be obtained within four weeks of study entry.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Required entry laboratory parameters: granulocytes \>/= 1,800/µl, platelet count \>/= 100,000/µl, bilirubin \< 2.0 mg/dL, alanine aminotransferase (ALT) \< 3 x upper limit of normal, and creatinine \< 3.0 mg/dL.
- Signed study-specific consent form prior to study entry.
Exclusion
- Patients who have evidence of metastatic disease in the major viscera and/or peritoneal seeding or ascites.
- Previous irradiation to the planned field; or previous chemotherapy for pancreatic cancer (Gemzar® or Taxol®).
- Malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder.
- Patients who have significant infection or other coexistent medical condition that would preclude protocol therapy.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00226746
Start Date
March 1 2003
End Date
June 1 2012
Last Update
September 18 2020
Active Locations (1)
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1
New York Methodist Hospital
Brooklyn, New York, United States, 11215