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

Alternate Title

UCN-01 and Carboplatin 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	MSGCC-0143 NCI-5533, NCT00036777, 5533

Objectives

1. Determine the maximum tolerated dose of UCN-01 and carboplatin when administered in combination in patients with advanced solid tumors.
2. Determine the dose-limiting toxicity and other toxic effects of this regimen in these patients.
3. Determine the pharmacokinetics of this regimen in these patients.
4. Determine, preliminarily, the antitumor effect of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed metastatic or unresectable solid tumor for which no standard curative or palliative therapy exists or is no longer effective



• Brain metastases allowed provided the following treatment requirements are met:
  • Asymptomatic or clinically stable disease after surgery or radiotherapy
  • No concurrent requirement for steroids or antiseizure medications
  • More than 2 weeks since prior therapy (e.g., surgery or CNS irradiation) for brain metastases
  • Recovered from prior therapy

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

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

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy and recovered
• Prior radiotherapy to the mediastinum is allowed provided LVEF is at least 45% by MUGA or echocardiogram

Surgery:

• See Disease Characteristics

Other:

• No other concurrent investigational or commercial agents for malignancy
• No concurrent combination antiretroviral therapy for HIV-positive patients

Patient Characteristics:

Age:

• 18 and over

Performance status:

• ECOG 0-2

  OR

• Karnofsky 60-100%

Life expectancy:

• More than 12 weeks

Hematopoietic:

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin normal
• AST/ALT no greater than 2.5 times upper limit of normal

Renal:

• Creatinine normal

  OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• See Radiotherapy
• History of coronary artery disease allowed provided LVEF is at least 45% by MUGA or echocardiogram
• No symptomatic cardiac disease

Pulmonary:

• History of pulmonary disease allowed provided FEV₁is at least 1 liter

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior allergic reactions to compounds of similar chemical or biological composition to study drugs
• No prior severe allergic reaction to cisplatin or carboplatin
• No insulin-dependent diabetes mellitus
• No other concurrent uncontrolled illness
• No ongoing or active infection
• No psychiatric illness or social situation that would preclude study compliance

Expected Enrollment

Approximately 3-30 patients will be accrued for this study.

Outline

This is a dose-escalation study.

Patients receive carboplatin IV over 1 hour followed by UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of carboplatin and UCN-01 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.

Hakimian RR, Edelman MJ, Bauer K, et al.: Phase I and pharmacokinetic (PK) study of the cyclin dependent kinase (CDK) inhibitor UCN-01 and carboplatin in solid tumors. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-598, 149, 2003.

Trial Contact Information

Trial Lead Organizations

Greenebaum Cancer Center at University of Maryland Medical Center

Martin Edelman, MD, Protocol chair		Ph: 410-328-2703; 800-888-8823 Email: medelman@umm.edu

Registry Information
Official Title		A Phase I Study Of UCN-01 In Combination With Carboplatin In Advanced Solid Tumors
Trial Start Date		2002-04-29
Registered in ClinicalTrials.gov		NCT00036777
Date Submitted to PDQ		2002-03-06
Information Last Verified		2004-11-22
NCI Grant/Contract Number		U01-CA69854

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