Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: 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.

PURPOSE: Phase I trial to study the effectiveness of combining UCN-01 with cisplatin in treating patients who have advanced solid tumors.

Further Study Information

OBJECTIVES:

• Determine the maximum tolerated dose of cisplatin when administered with UCN-01 in patients with advanced solid tumors.

• Determine 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 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.

PROJECTED ACCRUAL: A total of 9-30 patients will be accrued for this study within 12-18 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced or metastatic solid tumor that is not amenable to standard therapy

• No brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 4,000/mm^3

• Absolute neutrophil count at least 2,000/mm^3

• Platelet count at least 150,000/mm^3

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 coronary artery disease

• No New York Heart Association class III or IV heart disease

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study

• Must have central indwelling venous catheter

• No peripheral neuropathy greater than grade 1

• No prior allergic reaction to diuretics or antiemetics (e.g., 5-HT3 antagonists) to be administered during study

• No clinically significant hearing loss

• No uncontrolled concurrent illness that would preclude study therapy

• No medical, social, or psychological factor that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No more than 2 prior chemotherapy regimens

• At least 4 weeks since prior chemotherapy (at least 6 weeks for mitomycin or nitrosoureas) and recovered

• Prior cumulative dose of cisplatin no greater than 250 mg/m^2

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 4 weeks since prior radiotherapy and recovered

• No prior radiotherapy to the mediastinum

• No concurrent radiotherapy

Surgery:

• Recovered from prior surgery

Other:

• At least 30 days since prior investigational drugs

• No other concurrent investigational drugs

• No other concurrent anti-cancer agents

Trial Contact Information

Trial Lead Organizations/Sponsors

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Raymond P. Perez

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00012194
Information obtained from ClinicalTrials.gov on December 14, 2011

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