Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief 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.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of cisplatin when administered with UCN-01 in patients with advanced solid tumors. * Assess the toxicity and potential antitumor activity of this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. OUTLINE: This is a dose-escalation, multicenter study of cisplatin. Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours beginning on day 2. Treatment continues every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 1-6 patients receive escalating doses of cisplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 2-3 months for at least 1 year. PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 1 year.
Interventions
DRUGcisplatin
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed