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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Pancreatic Ductal

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

One-year overall survival rate

Principal Investigator

Hani Ashamalla, MD, FCCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York Methodist Hospital

Authority:

United States: Institutional Review Board

Study ID:

NYM # 179; AM-05

NCT ID:

NCT00226746

Start Date:

March 2003

Completion Date:

December 2010

Related Keywords:

  • Carcinoma, Pancreatic Ductal
  • Pancreatic Cancer
  • Hyperfractionated Radiation Therapy
  • Gemcitabine
  • Paclitaxel
  • Carcinoma, Pancreatic Ductal
  • Carcinoma
  • Pancreatic Neoplasms
  • Carcinoma, Pancreatic Ductal

Name

Location

New York Methodist HospitalBrooklyn, New York  11215-3609