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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
Hani Ashamalla, MD, FCCP
Information provided by:
New York Methodist Hospital Identifier:
First received: September 23, 2005
Last updated: March 20, 2007
Last verified: September 2006
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: 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.

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.
  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 identifier: 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
  More Information

Publications: Identifier: NCT00226746     History of Changes
Other Study ID Numbers: NYM # 179; AM-05
Study First Received: September 23, 2005
Last Updated: March 20, 2007

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
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Tubulin Modulators processed this record on June 26, 2017