ClinicalTrials.Veeva

Menu

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

N

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Withdrawn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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems