Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer
Recruitment status was: Active, not recruiting
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.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: gemcitabine hydrochloride
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I Study of Continuous Infusion Gemcitabine|
|Study Start Date:||March 2000|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020644
|United States, Illinois|
|Lutheran General Cancer Care Center|
|Park Ridge, Illinois, United States, 60068|
|Study Chair:||Brian L. Samuels, MD||Lutheran General Hospital|