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Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors

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ClinicalTrials.gov Identifier: NCT00070096
Recruitment Status : Completed
First Posted : October 7, 2003
Last Update Posted : June 24, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE October 3, 2003
First Posted Date  ICMJE October 7, 2003
Last Update Posted Date June 24, 2013
Study Start Date  ICMJE August 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2007)
  • Efficacy
  • Safety
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
Official Title  ICMJE A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well ixabepilone works in treating patients with metastatic germ cell tumors that are refractory to cisplatin.

Detailed Description

OBJECTIVES:

  • Determine the efficacy of ixabepilone in patients with metastatic cisplatin-refractory germ cell tumors.
  • Determine the safety of this drug in these patients.

OUTLINE: Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 10-29 patients will be accrued for this study within 1.3-4 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Brain and Central Nervous System Tumors
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
Intervention  ICMJE Drug: ixabepilone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 15, 2007)
29
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically confirmed germ cell tumor (GCT) (seminoma or non-seminoma) meeting the following criteria:

    • Measurable metastatic disease by one of the following methods:

      • Radiography

        • If eligibility is defined by measurable disease only, there must be at least 1 site that has not been previously irradiated
      • Alpha-fetoprotein greater than 15 ng/mL and/or ß-human chorionic gonadotropin greater than 2.2 mIU/L
  • Previously treated progressive disease meeting 1 of the following criteria:

    • Not a candidate for potentially curative therapy OR has already received high-dose chemotherapy regimens (prior paclitaxel allowed)
    • Deemed to be cisplatin-refractory after prior cisplatin-based regimen AND does not want to have potentially curative high-dose therapy (mediastinal or primary refractory GCT)
    • Prior treatment with 1 cisplatin-based regimen (primary mediastinal nonseminomatous GCT)

PATIENT CHARACTERISTICS:

Age

  • 16 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic

  • Bilirubin no greater than 1.5 times normal
  • SGOT no greater than 2 times upper limit of normal

Renal

  • Creatinine no greater than 2.2 mg/dL

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • See Disease Characteristics
  • No other concurrent cytotoxic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • No other concurrent experimental or commercial anticancer medications or therapies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00070096
Other Study ID Numbers  ICMJE CDR0000329992
MSKCC-03041
NCI-6022
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Gnanamba V. Kondagunta, MD Memorial Sloan Kettering Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date April 2006

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