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

New York Presbyterian Brooklyn Methodist Hospital

Status and phase: Withdrawn; Phase 2

Conditions: Carcinoma, Pancreatic Ductal

Treatments: Drug: Paclitaxel and gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00226746

NYM # 179 AM-05;

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Paclitaxel and Gemcitabine

Experimental group

Description:

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.

Treatment:

Drug: Paclitaxel and gemcitabine