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

Study Overview
=================
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.

Official Title
-----------------
Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Drug: 7-hydroxystaurosporine
* Drug: cisplatin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 7-hydroxystaurosporine|nan|
|Drug: cisplatin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
unspecified adult solid tumor, protocol specific