Continuous Infusion Gemcitabine in Treating Patients With Advanced Metastatic Cancer
This trial is active, not recruiting.
|Condition||unspecified adult solid tumor, protocol specific|
|Sponsor||Lutheran General Hospital|
|Start date||March 2000|
|Trial identifier||NCT00020644, CDR0000068691, LGH-3000, NCI-V01-1660|
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.
Male or female participants at least 18 years old.
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
|Official title||Phase I Study of Continuous Infusion Gemcitabine|
|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.|
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