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UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
This study has been completed.
Study NCT00006464   Information provided by National Cancer Institute (NCI)
First Received: November 6, 2000   Last Updated: July 23, 2008   History of Changes

November 6, 2000
July 23, 2008
March 2001
 
 
 
Complete list of historical versions of study NCT00006464 on ClinicalTrials.gov Archive Site
 
 
 
UCN-01 and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

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

OBJECTIVES:

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

Patients receive cisplatin IV over 1 hour on day 1 and UCN-01 IV continuously over 36-72 hours beginning on day 2. Treatment continues every 4 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 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 1 year.

Phase I
Interventional
Treatment
Unspecified Adult Solid Tumor, Protocol Specific
  • Drug: 7-hydroxystaurosporine
  • Drug: cisplatin
 
Lara PN Jr, Mack PC, Synold T, Frankel P, Longmate J, Gumerlock PH, Doroshow JH, Gandara DR. The cyclin-dependent kinase inhibitor UCN-01 plus cisplatin in advanced solid tumors: a California cancer consortium phase I pharmacokinetic and molecular correlative trial. Clin Cancer Res. 2005 Jun 15;11(12):4444-50.

*   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 or cytologically confirmed advanced or metastatic solid tumor incurable by surgery or other standard therapy
  • Tumor site accessible by biopsy
  • No brain metastasis

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • More than 3 months

Hematopoietic:

  • WBC at least 4,500/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 New York Heart Association class III or IV congestive heart failure

Other:

  • No peripheral neuropathy greater than grade I
  • No history of allergic reactions to diuretics or antiemetics (e.g., 5-HT3 antagonists) that would preclude study
  • No other uncontrolled illness that would preclude study, including intolerance to vigorous hydration
  • No medical, social, or psychological factors that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • No greater than 2 prior chemotherapy regimens
  • Prior cisplatin allowed if cumulative dose no greater than 400 mg/m2

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from any prior surgery

Other:

  • At least 30 days since prior investigational drugs
  • No other concurrent investigational drugs
  • No other concurrent anticancer agents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006464
 
CDR0000068274, CHNMC-PHI-28, NCI-T99-0065
Beckman Research Institute
National Cancer Institute (NCI)
Study Chair: David R. Gandara, MD University of California, Davis
National Cancer Institute (NCI)
August 2002

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