Overview
UCN-01, Fluorouracil, and Leucovorin in Treating Patients With Metastatic or Unresectable Solid Tumors
Status:
Completed
Completed
Trial end date:
1969-12-31
1969-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining UCN-01, fluorouracil, and leucovorin in treating patients who have metastatic or unresectable solid tumors.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
National Cancer Institute (NCI)Treatments:
7-hydroxystaurosporine
Calcium
Fluorouracil
Leucovorin
Levoleucovorin
Staurosporine
Criteria
DISEASE CHARACTERISTICS:- Histologically confirmed solid tumor that is metastatic or unresectable and for which
no standard curative or palliative measures exist or are effective
- No brain metastases or primary CNS malignancy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- AST and ALT no greater than 3 times upper limit of normal
Renal
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular
- No known active coronary artery disease
Pulmonary
- No pulmonary dysfunction
Other
- HIV negative
- No history of unusually severe and/or prolonged toxicity during prior therapy with
fluorouracil (5-FU) or 5-FU prodrugs
- No diabetes mellitus requiring insulin or oral hypoglycemic therapy
- No ongoing or active infection requiring IV antibiotics
- No other serious concurrent medical illness that would preclude study
- No psychiatric illness or social situations that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior immunotherapy and recovered
- No concurrent cytokines during the first course of therapy
Chemotherapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and
recovered
Endocrine therapy
- No concurrent systemic corticosteroids
Radiotherapy
- At least 2 weeks since prior radiotherapy and recovered
- No prior pulmonary or mediastinal radiation exceeding 40 Gy
Surgery
- Recovered from prior surgery
Other
- No other concurrent investigational agents
- No concurrent cimetidine
- No concurrent sorivudine or brivudine