Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer

June 20, 2013 updated by: Memorial Sloan Kettering Cancer Center

A Phase I Trial of Combined Modality Gemcitabine Plus Radiation Therapy for Patients With Locally Advanced Unresectable Pancreatic Adenocarcinoma

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of gemcitabine plus radiation therapy in treating patients with pancreatic cancer that can not be surgically removed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine in combination with radiation therapy to patients with locally advanced and/or unresectable adenocarcinoma of the pancreas. II. Determine the dose limiting toxic effects of this combination therapy in these patients. III. Evaluate the ability of these patients to tolerate induction and then maintenance therapy with gemcitabine preceding and following combination therapy. IV. Evaluate the efficacy (response rate, pattern of failure, and survival) of this combination therapy in these patients.

OUTLINE: This is a dose escalation study of gemcitabine. Part I: Patients receive gemcitabine as a continuous infusion over 30 minutes once weekly for 3 weeks followed by 1 week of rest. Part II: Gemcitabine IV is administered as a 30 minute infusion twice a week (Monday and Thursday) for 5-6 weeks. Patients receive radiation therapy 5 days a week for 5-6 weeks. In the absence of dose-limiting toxicity (DLT) in the first 6 patients treated, subsequent cohorts of 6 patients each receive escalating doses of gemcitabine on the same schedule. If DLT occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. Part III: In the absence of toxicity and disease progression, patients continue gemcitabine for 3 additional courses. Maintenance gemcitabine starts 4 weeks after the completion of radiation therapy and is administered once weekly for 3 weeks followed by 1 week of rest. Patients are followed until death.

PROJECTED ACCRUAL: This study will accrue 15-30 patients in approximately 24 months.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Histologically or cytologically proven locally advanced and/or unresectable adenocarcinoma of the pancreas No metastatic disease No completely resected pancreatic cancer

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% OR ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No congestive heart failure No New York Heart Association class III and IV heart disease Other: Not pregnant No concurrent medical problems that would increase the side effects or morbidity of chemoradiation No concurrent medical condition that would make patient ineligible to receive external beam radiation such as: Crohn's disease Inflammatory bowel disease No active infection requiring systemic antibiotics

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior gemcitabine No prior chemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the pancreas Surgery: Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: David Paul Kelsen, MD, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1998

Primary Completion (Actual)

March 1, 2002

Study Completion (Actual)

March 1, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

December 1, 2003

First Posted (Estimate)

December 2, 2003

Study Record Updates

Last Update Posted (Estimate)

June 21, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-019
  • CDR0000066451 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-H98-0020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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