Fluorouracil Plus UCN-01 in Treating Patients With Advanced or Refractory Solid Tumors

• Status: Completed
• Trial end date: 2002-09-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug.

PURPOSE: Phase I trial to study the effectiveness of fluorouracil plus UCN-01 in treating patients who have advanced or refractory solid tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: 7-hydroxystaurosporine; Fluorouracil; Staurosporine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists

• Measurable or evaluable disease

• No CNS metastasis or primary CNS malignancy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3,500/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• SGOT and SGPT no greater than 2.5 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance greater than 60 mL/min

Cardiovascular:

• No history of coronary artery disease documented by prior myocardial infarction, angiography, or coronary-artery bypass grafting

• No cardiac arrhythmias or congestive heart failure within the past 6 months

• Stable atrial fibrillation on standard treatment allowed at discretion of investigator

Pulmonary:

• DLCO at least 60% of predicted

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 2 months after study

• No active serious or uncontrolled infection

• HIV negative

• No diabetes

• No other medical condition that would preclude study

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered

• Prior fluorouracil allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior mediastinal radiotherapy

• At least 4 weeks since prior radiotherapy and recovered

Surgery:

• Not specified

Other:

• No concurrent anticonvulsant medications