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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by New York Methodist Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Hani Ashamalla, MD, FCCP
Information provided by:
New York Methodist Hospital
ClinicalTrials.gov Identifier:
NCT00226746
First received: September 23, 2005
Last updated: March 20, 2007
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Carcinoma, Pancreatic Ductal
Drug: Paclitaxel and gemcitabine
Procedure: Hyperfractionated external beam irradiation
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Phase II Trial of Weekly Gemcitabine, Paclitaxel, and Hyperfractionated External Irradiation (63.80 GY) for Locally Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by New York Methodist Hospital:

Primary Outcome Measures:
  • One-year overall survival rate

Secondary Outcome Measures:
  • Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary
  • Occurrence of pathological response or shrinkage of the tumor (becomes resectable)

Estimated Enrollment: 70
Study Start Date: March 2003
Estimated Study Completion Date: December 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226746

Contacts
Contact: Adel Guirguis, MD, MS 718-780-3677 adg9003@nyp.org
Contact: Suzan Shenouda, RN 718-780-3677 adg9003@nyp.org

Locations
United States, New York
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Adel Guirguis, MD, MS    718-780-3677    adg9003@nyp.org   
Contact: Suzan Shenouda, RN    718-780-3677    adg9003@nyp.org   
Principal Investigator: Hani Ashamalla, MD, FCCP         
Sub-Investigator: Frank Colella, MD         
Sub-Investigator: David Dosik, MD         
Sub-Investigator: Muthuswamy Krishnamurthy, MD         
Sponsors and Collaborators
New York Methodist Hospital
Hani Ashamalla, MD, FCCP
Investigators
Principal Investigator: Hani Ashamalla, MD, FCCP New York Methodist Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00226746     History of Changes
Other Study ID Numbers: NYM # 179; AM-05
Study First Received: September 23, 2005
Last Updated: March 20, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by New York Methodist Hospital:
Pancreatic Cancer
Hyperfractionated Radiation Therapy
Gemcitabine
Paclitaxel
Carcinoma, Pancreatic Ductal

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Pancreatic Ductal
Pancreatic Neoplasms
Adenocarcinoma
Carcinoma, Ductal
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Pancreatic Diseases
Gemcitabine
Paclitaxel
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 29, 2014