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

City of Hope Medical Center

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

7-hydroxystaurosporineDRUG

cisplatinDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

City of Hope Medical Group

Pasadena, California, United States

University of California Davis Cancer Center

Sacramento, California, United States

Norris Cotton Cancer Center

Lebanon, New Hampshire, United States

Data from ClinicalTrials.gov

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