Efficacy Study of Gemcitabine, Paclitaxel, and Irradiation in the Treatment of Pancreatic Cancer
Conditions
Carcinoma, Pancreatic Ductal
Conditions: official terms
Carcinoma, Pancreatic Ductal - Pancreatic Neoplasms
Conditions: Keywords
Pancreatic Cancer, Hyperfractionated Radiation Therapy, Gemcitabine, Paclitaxel, Carcinoma, Pancreatic Ductal
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Paclitaxel and gemcitabine Type: Drug
Name: Hyperfractionated external beam irradiation Type: Procedure
Overall Status
Recruiting
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 locally advanced pancreatic cancer.
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 at a dose level of 75 mg/m2/week in addition to our prior protocol.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Pathologically confirmed adenocarcinoma of the pancreas.

2. Patients must have locally advanced/unresectable disease based on institutional standardized criteria of unresectability.

3. Patients with residual disease after resection (R-1 or –2, micro and macroscopic residual) are eligible.

4. Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation.

5. All malignant disease must be encompassable within a single irradiation field (12 x 12 cm maximum).

6. All patients must have radiographically assessable disease.

7. Electrocardiogram (EKG), chest x-ray, abdominal computed tomography (CT)/magnetic resonance imaging (MRI) scan must be obtained within four weeks of study entry.

8. Zubrod performance status 0-1.

9. Required entry laboratory parameters: granulocytes >/= 1,800/µl, platelet count >/= 100,000/µl, bilirubin < 2.0 mg/dL, ALT < 3 x upper limit of normal, and creatinine < 3.0 mg/dL.

10. Signed study-specific consent form prior to study entry.

Exclusion Criteria:

1. Patients who have evidence of metastatic disease in the major viscera and/or peritoneal seeding or ascites.

2. Previous irradiation to the planned field; or previous chemotherapy for pancreatic cancer (Gemzar® or Taxol®).

3. Malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder.

4. Patients who have significant infection or other coexistent medical condition that would preclude protocol therapy.
Location
New York Methodist Hospital
Brooklyn, New York, United States
Status: Recruiting
Contact: Adel Guirguis, MD, MS - 718-780-3677 - adg9003@nyp.org
Start Date
March 2003
Completion Date
December 2010
Sponsors
New York Methodist Hospital
Source
New York Methodist Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page