Gemcitabine Plus Radiation Therapy in Treating Patients With Pancreatic Cancer

NCT ID: NCT00003426

Last Updated: 2013-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-04-30
• Study Completion Date: 2002-03-31

Brief Summary

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.

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.

Conditions

Pancreatic Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

gemcitabine hydrochloride

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

David Paul Kelsen, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CDR0000066451

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-H98-0020

Identifier Type: -

Identifier Source: secondary_id

98-019

Identifier Type: -

Identifier Source: org_study_id