Efficacy Study of Gemcitabine, Paclitaxel, and Irradiation in the Treatment of Pancreatic Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter Phase II Trial of Weekly Gemcitabine, Paclitaxel, and Hyperfractionated External Irradiation (63.80 GY) for Locally Advanced Pancreatic Cancer

Conditions
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Carcinoma, Pancreatic Ductal

Intervention / Treatment
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* Drug: Paclitaxel and gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Radiation Therapy: 63.80 Gy (1.1 Gy BID X 58 fractions), Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36. Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel and Gemcitabine<br>Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions), Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36. Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36. | Drug: Paclitaxel and gemcitabine<br>* Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions) Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36. Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One-year overall survival rate | Follow up for survival will be done to know this outcome | Up to June 2010 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary | Follow up for occurrence of adverse events will be done to know this outcome | year 2010 | 
| Occurrence of pathological response or shrinkage of the tumor (becomes resectable) | Follow up for tumor response will be done to know this outcome | year 2010 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic Cancer, Hyperfractionated Radiation Therapy, Gemcitabine, Paclitaxel, Carcinoma, Pancreatic Ductal