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
Recruitment status was Recruiting
Sponsor:
New York Methodist Hospital
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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:
- Pathologically confirmed adenocarcinoma of the pancreas.
- Patients must have locally advanced/unresectable disease based on institutional standardized criteria of unresectability.
- Patients with residual disease after resection (R-1 or –2, micro and macroscopic residual) are eligible.
- Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation.
- All malignant disease must be encompassable within a single irradiation field (12 x 12 cm maximum).
- All patients must have radiographically assessable disease.
- Electrocardiogram (EKG), chest x-ray, abdominal computed tomography (CT)/magnetic resonance imaging (MRI) scan must be obtained within four weeks of study entry.
- Zubrod performance status 0-1.
- 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.
- Signed study-specific consent form prior to study entry.
Exclusion Criteria:
- Patients who have evidence of metastatic disease in the major viscera and/or peritoneal seeding or ascites.
- Previous irradiation to the planned field; or previous chemotherapy for pancreatic cancer (Gemzar® or Taxol®).
- Malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder.
- Patients who have significant infection or other coexistent medical condition that would preclude protocol therapy.
Contacts and Locations
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 Pancreatic Neoplasms Carcinoma, Pancreatic Ductal Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Carcinoma, Ductal Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary |
Gemcitabine Paclitaxel Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents |
ClinicalTrials.gov processed this record on June 13, 2013