UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors

• Status: Completed
• Trial end date: 2008-06-01
• 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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of UCN-01 and cisplatin in treating patients who have advanced or metastatic solid tumors.

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

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: 7-hydroxystaurosporine; Cisplatin; Staurosporine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced or metastatic solid tumor incurable by surgery or other standard therapy

• Tumor site accessible by biopsy

• No brain metastasis

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 4,500/mm3

• Absolute neutrophil count at least 2,000/mm3

• Platelet count at least 150,000/mm3

Hepatic:

• Bilirubin normal

• SGOT no greater than 2.5 times upper limit of normal

Renal:

• Creatinine normal

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No New York Heart Association class III or IV congestive heart failure

Other:

• No peripheral neuropathy greater than grade I

• No history of allergic reactions to diuretics or antiemetics (e.g., 5-HT3 antagonists) that would preclude study

• No other uncontrolled illness that would preclude study, including intolerance to vigorous hydration

• No medical, social, or psychological factors that would preclude study

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

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

• No greater than 2 prior chemotherapy regimens

• Prior cisplatin allowed if cumulative dose no greater than 400 mg/m2

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

Surgery:

• See Disease Characteristics

• Recovered from any prior surgery

Other:

• At least 30 days since prior investigational drugs

• No other concurrent investigational drugs

• No other concurrent anticancer agents