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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2006 by New York Methodist Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00226746
First Posted: September 27, 2005
Last Update Posted: March 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hani Ashamalla, MD, FCCP
Information provided by:
New York Methodist Hospital
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 23, 2005
First Posted: September 27, 2005
Last Update Posted: March 21, 2007
Last Verified: September 2006

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

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