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UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors
This study has been completed.
Study NCT00036777   Information provided by National Cancer Institute (NCI)
First Received: May 13, 2002   Last Updated: July 23, 2008   History of Changes

May 13, 2002
July 23, 2008
April 2002
 
 
 
Complete list of historical versions of study NCT00036777 on ClinicalTrials.gov Archive Site
 
 
 
UCN-01 and Carboplatin in Treating Patients With Advanced Solid Tumors
A Phase I Study Of UCN-01 In Combination With Carboplatin In Advanced Solid Tumors

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.

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.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: 7-hydroxystaurosporine
  • Drug: carboplatin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00036777
 
CDR0000069321, MSGCC-0143, NCI-5533
University of Maryland Greenebaum Cancer Center
National Cancer Institute (NCI)
Study Chair: Martin J. Edelman, MD University of Maryland Greenebaum Cancer Center
National Cancer Institute (NCI)
November 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP