Phase I Study of Continuous Infusion Gemcitabine
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Study of Continuous Infusion Gemcitabine
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Brian L. Samuels, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Lutheran General Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000068691
NCT ID:
NCT00020644
Start Date:
March 2000
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
