This trial is active, not recruiting.

Condition unspecified adult solid tumor, protocol specific
Treatment gemcitabine hydrochloride
Phase phase 1
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).