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

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ClinicalTrials.gov Identifier: NCT00226746
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
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 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)
Actual Enrollment : 70 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

Radiation Therapy: 63.80 Gy (1.1 Gy BID X 58 fractions), Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36.

Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36.

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
Actual Study Start Date : March 2003
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Paclitaxel and Gemcitabine

Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions), Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36.

Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36.

Drug: Paclitaxel and gemcitabine

Radiation Therapy: 63.80 Gy (1.1 Gy twice a day X 58 fractions) Paclitaxel: 60 mg/m2 / week by 1- hour IV infusion on days 1, 8, 15, 22, 29, and 36.

Gemcitabine: 75 mg/m2 / week on days 1, 8, 15, 22, 29, and 36.




Primary Outcome Measures :
  1. One-year overall survival rate [ Time Frame: Up to June 2010 ]
    Follow up for survival will be done to know this outcome


Secondary Outcome Measures :
  1. Occurrence of grade 3 or higher toxicity in the gastrointestinal or pulmonary [ Time Frame: year 2010 ]
    Follow up for occurrence of adverse events will be done to know this outcome

  2. Occurrence of pathological response or shrinkage of the tumor (becomes resectable) [ Time Frame: year 2010 ]
    Follow up for tumor response will be done to know this outcome



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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 encompassed 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. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  9. Required entry laboratory parameters: granulocytes >/= 1,800/µl, platelet count >/= 100,000/µl, bilirubin < 2.0 mg/dL, alanine aminotransferase (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 ClinicalTrials.gov identifier (NCT number): NCT00226746


Locations
United States, New York
New York Methodist Hospital
Brooklyn, New York, United States, 11215
Sponsors and Collaborators
New York Methodist Hospital
Investigators
Principal Investigator: Hani Ashamalla, MD, FCCP New York Methodist Hospital

Publications:
Responsible Party: New York Methodist Hospital
ClinicalTrials.gov Identifier: NCT00226746     History of Changes
Other Study ID Numbers: NYM # 179; AM-05
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

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