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Phase I Study of Continuous Infusion Gemcitabine in Patients With Advanced Metastatic Malignancies

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase I

Treatment

Closed

18 and over

Other

LGH-3000
NCI-V01-1660, NCT00020644

Objectives

Determine the maximum tolerated dose of continuous infusion gemcitabine in patients with metastatic malignancies.
Determine the toxicity profile of this drug in these patients.

Entry Criteria

Disease Characteristics:

Diagnosis of an advanced metastatic malignancy for which no curative therapy exists

Prior/Concurrent Therapy:

Biologic therapy

Not specified

Chemotherapy

Prior short-infusion gemcitabine allowed

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Patient Characteristics:

Age:

18 and over

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 2,000/mm³
Platelet count at least 100,000/mm³

Hepatic:

Bilirubin no greater than 2.0 mg/dL

Renal:

Creatinine no greater than 2.0 mg/dL

Pulmonary:

Corrected DLCO at least 60% expected

Other:

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

Expected Enrollment

A total of 27 patients will be accrued for this study.

Outline

This is a dose-escalation study.

Patients on dose levels 1-5 receive gemcitabine IV continuously over 72 hours on week 1. Patients on dose levels 6 and 7 receive gemcitabine IV continuously over 72 hours on weeks 1-3. Courses repeat every 2 weeks (for patients on dose levels 1-5) and every 4 weeks (for patients on dose levels 6 and 7) in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity.

Trial Contact Information

Trial Lead Organizations

Advocate Lutheran General Cancer Care Center

Brian Samuels, MD, Protocol chair(Contact information may not be current)
Ph: 847-268-8200
Email: bsamuels@oncmed.net

Registry Information

Official Title		Phase I Study of Continuous Infusion Gemcitabine

Trial Start Date		2000-03-30

Registered in ClinicalTrials.gov		NCT00020644

Date Submitted to PDQ		2001-05-01

Information Last Verified		2004-04-27

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.