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CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00017446
First received: June 6, 2001
Last updated: January 3, 2014
Last verified: September 2002
June 6, 2001
January 3, 2014
October 2000
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Complete list of historical versions of study NCT00017446 on ClinicalTrials.gov Archive Site
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CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Phase II Evaluation Of CP4071 In Previously Treated Advanced Sarcomas

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of CP4071 in treating patients who have locally advanced or metastatic soft tissue sarcoma.

OBJECTIVES:

  • Determine the efficacy, in terms of response rate, of CP4071 in patients with previously treated, locally advanced or metastatic soft tissue sarcoma.
  • Determine the clinical toxic effects of this drug in these patients.

OUTLINE: Patients receive oral CP4071 daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Interventional
Phase 2
Primary Purpose: Treatment
Sarcoma
Drug: CP4071
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
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DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed soft tissue sarcoma

    • Metastatic or locally advanced
    • Failed at least 1 prior therapy
  • Measurable disease outside prior irradiation field
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • SWOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

  • Creatinine less than 1.5 times ULN
  • Calcium less than ULN
  • Potassium normal

Other:

  • No other malignancy within the past 5 years except stage I or II cancer in complete remission, carcinoma in situ of the cervix, or basal cell or squamous cell skin cancer
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior biologic response modifier therapy allowed

Chemotherapy:

  • No more than 3 prior chemotherapy regimens for advanced, recurrent, or metastatic disease
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy for malignancy

Radiotherapy:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • At least 4 weeks since prior surgery and recovered

Other:

  • No other concurrent cardiac glycosides
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00017446
CDR0000068689
CPMC-IRB-9825
NCI-G01-1952
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Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Robert N. Taub, MD, PhD Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
September 2002

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