Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

July 11, 2001

Last Updated Date

July 23, 2008

Start Date ^ICMJE

March 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00020644 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer

Official Title ^ICMJE

Phase I Study of Continuous Infusion Gemcitabine

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of gemcitabine given as a continuous infusion in treating patients who have advanced metastatic cancer.

Detailed Description

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.

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.

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^ICMJE

Drug: gemcitabine hydrochloride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 2,000/mm^3
Platelet count at least 100,000/mm^3

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Prior short-infusion gemcitabine allowed

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00020644

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068691, LGH-3000, NCI-V01-1660

Study Sponsor ^ICMJE

Lutheran General Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Brian L. Samuels, MD

Lutheran General Hospital

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP