Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	DMS-9934 NCI-2331, NCT00012194, 2331

Objectives

1. Determine the maximum tolerated dose of cisplatin when administered with UCN-01 in patients with advanced solid tumors.
2. Determine the toxicity and potential antitumor activity of this regimen in these patients.
3. Determine the pharmacokinetics of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed advanced or metastatic solid tumor that is not amenable to standard therapy
• No brain metastases

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/m²

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC at least 4,000/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 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

Expected Enrollment

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

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.

Perez RP, Lewis LD, Beelen AP, et al.: Modulation of cell cycle progression in human tumors: a pharmacokinetic and tumor molecular pharmacodynamic study of cisplatin plus the Chk1 inhibitor UCN-01 (NSC 638850). Clin Cancer Res 12 (23): 7079-85, 2006.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Raymond Perez, MD, Protocol chair		Ph: 603-650-6633; 800-639-6918 Email: raymond.p.perez@hitchcock.org

Registry Information
Official Title		Phase I Dose Escalation Study Of UCN-01 (NSC 638850) Plus Cisplatin In Advanced Malignant Solid Tumors
Trial Start Date		2001-03-19
Trial Completion Date		2008-04-22
Registered in ClinicalTrials.gov		NCT00012194
Date Submitted to PDQ		2001-01-19
Information Last Verified		2007-05-27
NCI Grant/Contract Number		CA23108

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