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
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 11, 2001
Last updated: August 6, 2013
Last verified: April 2004

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 1

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

Resource links provided by NLM:

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

Study Start Date: March 2000
Detailed Description:


  • 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.


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


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



  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


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


  • Bilirubin no greater than 2.0 mg/dL


  • Creatinine no greater than 2.0 mg/dL


  • Corrected DLCO at least 60% expected


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


Biologic therapy

  • Not specified


  • Prior short-infusion gemcitabine allowed

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT00020644

United States, Illinois
Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068
Sponsors and Collaborators
Lutheran General Hospital
Study Chair: Brian L. Samuels, MD Lutheran General Hospital
  More Information Identifier: NCT00020644     History of Changes
Other Study ID Numbers: LGH-3000  CDR0000068691  NCI-V01-1660 
Study First Received: July 11, 2001
Last Updated: August 6, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 30, 2016