Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2004 by National Cancer Institute (NCI). Recruitment status was Active, not recruiting

First Received on July 11, 2001. Last Updated on July 23, 2008 History of Changes

Sponsor:	Lutheran General Hospital
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020644

Purpose

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.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: gemcitabine hydrochloride	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase I Study of Continuous Infusion Gemcitabine

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

March 2000

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020644

Locations

United States, Illinois
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068

Sponsors and Collaborators

Lutheran General Hospital

Investigators

Study Chair:

Brian L. Samuels, MD

Lutheran General Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00020644 History of Changes
Other Study ID Numbers:	CDR0000068691, LGH-3000, NCI-V01-1660
Study First Received:	July 11, 2001
Last Updated:	July 23, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 12, 2012