Park Ridge,
Illinois
60068
Purpose:
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.
Study summary:
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.
Criteria:
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