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

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. Identifier: NCT00226746
Recruitment Status : Unknown
Verified September 2006 by New York Methodist Hospital.
Recruitment status was:  Recruiting
First Posted : September 27, 2005
Last Update Posted : March 21, 2007
Hani Ashamalla, MD, FCCP
Information provided by:
New York Methodist Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Pancreatic Ductal Drug: Paclitaxel and gemcitabine Procedure: Hyperfractionated external beam irradiation Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
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
Study Start Date : March 2003
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. One-year overall survival rate

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00226746

Contact: Adel Guirguis, MD, MS 718-780-3677
Contact: Suzan Shenouda, RN 718-780-3677

United States, New York
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Adel Guirguis, MD, MS    718-780-3677   
Contact: Suzan Shenouda, RN    718-780-3677   
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
Principal Investigator: Hani Ashamalla, MD, FCCP New York Methodist Hospital

Publications: Identifier: NCT00226746     History of Changes
Other Study ID Numbers: NYM # 179; AM-05
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: March 21, 2007
Last Verified: September 2006

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

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