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

This study has been completed.

Sponsors and Collaborators: Beckman Research Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006464
  Purpose

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.


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

MedlinePlus related topics:   Cancer   

Drug Information available for:   Cisplatin    UCN 01   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase I Dose Escalation Study of UCN-01 (NSC 638850) Plus Cisplatin in Advanced Malignant Solid Tumors

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

Study Start Date:   March 2001

Detailed Description:

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.

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

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006464

Locations
United States, California
City of Hope Medical Group    
      Pasadena, California, United States, 91105
University of California Davis Cancer Center    
      Sacramento, California, United States, 95817
USC/Norris Comprehensive Cancer Center and Hospital    
      Los Angeles, California, United States, 90033-0804
United States, New Hampshire
Norris Cotton Cancer Center    
      Lebanon, New Hampshire, United States, 03756-0002

Sponsors and Collaborators
Beckman Research Institute
National Cancer Institute (NCI)

Investigators
Study Chair:     David R. Gandara, MD     University of California, Davis    
  More Information


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

Publications of Results:

Study ID Numbers:   CDR0000068274, CHNMC-PHI-28, NCI-T99-0065
First Received:   November 6, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006464
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:
Cisplatin
Staurosporine
7-hydroxystaurosporine

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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