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UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors
This study has been completed.
Sponsors and Collaborators: University of Maryland Greenebaum Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00036777
  Purpose

RATIONALE: UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining UCN-01 with carboplatin may kill more tumor cells.

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


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: 7-hydroxystaurosporine
Drug: carboplatin
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Carboplatin UCN 01
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study Of UCN-01 In Combination With Carboplatin In Advanced Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2002
Detailed Description:

OBJECTIVES:

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

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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

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 FEV_1is 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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036777

Locations
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland Greenebaum Cancer Center
Investigators
Study Chair: Martin J. Edelman, MD University of Maryland Greenebaum Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
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.

Study ID Numbers: CDR0000069321, MSGCC-0143, NCI-5533
Study First Received: May 13, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00036777  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Staurosporine
Carboplatin
7-hydroxystaurosporine

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009