Carcinoma, Pancreatic Ductal
Conditions
Keywords
Pancreatic Cancer, Hyperfractionated Radiation Therapy, Gemcitabine, Paclitaxel, Carcinoma, Pancreatic Ductal
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 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.
Interventions
DRUGPaclitaxel and gemcitabine
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.
Sponsors
New York Presbyterian Brooklyn Methodist Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 encompassed 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. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 9. 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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One-year overall survival rate | Up to June 2010 | Follow up for survival will be done to know this outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary | year 2010 | Follow up for occurrence of adverse events will be done to know this outcome |
| Occurrence of pathological response or shrinkage of the tumor (becomes resectable) | year 2010 | Follow up for tumor response will be done to know this outcome |
Countries
United States
Outcome results
None listed