ucn-01 and cisplatin in treating patients with advanced or metastatic solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

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.

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.

Eligibility 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

Keywords: unspecified adult solid tumor, protocol specific