Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors
Phase I trial to study the effectiveness of combining UCN-01 with cisplatin in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help cisplatin kill more cancer cells by making tumor cells more sensitive to the drug.
OBJECTIVES:
I. To establish the maximum tolerated dose (MTD) of cisplatin in combination with UCN-01 in
patients with advanced malignancies.
II. To assess the toxicity and observe the potential antitumor activity of UCN-01 plus
cisplatin in advanced malignancies at each dose level studies.
III. To determine the pharmacokinetics of UCN-01 and cisplatin on this treatment schedule.
IV. To perform laboratory correlative studies to investigate intermediate molecular markers
of the activity of UCN-01 and cisplatin at the cellular level.
OUTLINE: This is a dose-escalation study of cisplatin.
Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72
hours on day 2. Treatment repeats every 4 weeks for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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