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

Withdrawn before enrolling · Phase 2

Conditions studied: Carcinoma, Pancreatic Ductal

In brief

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.

Key facts

Study ID

NCT00226746

Run by

New York Presbyterian Brooklyn Methodist Hospital

People needed

0

Starts

2003-03-01

Expected to finish

2012-06-01

Last updated by the study team

2020-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• New York Methodist Hospital — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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