Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00020644
- Lead Sponsor
- Advocate Lutheran General Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Lutheran General Cancer Care Center
🇺🇸Park Ridge, Illinois, United States
Lutheran General Cancer Care Center🇺🇸Park Ridge, Illinois, United States