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.

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Procedure: chemotherapy  Drug: cisplatin  Drug: UCN-01	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the maximum tolerated dose of cisplatin when administered with UCN-01 in patients with advanced solid tumors. II. Assess the toxicity and potential antitumor activity of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

California
      City of Hope Medical Group, Pasadena,  California,  91105,  United States
      University of California Davis Cancer Center, Sacramento,  California,  95817,  United States
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States
New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756-0002,  United States

Study chairs or principal investigators

David R. Gandara,  Study Chair,  Beckman Research Institute   

Study ID Numbers:  CDR0000068274; CHNMC-PHI-28; NCI-T99-0065
Record last reviewed:  May 2003
Last Updated:  October 13, 2004
Record first received:  November 6, 2000
ClinicalTrials.gov Identifier:  NCT00006464
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08