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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00070096
First received: October 3, 2003
Last updated: June 21, 2013
Last verified: April 2006

October 3, 2003
June 21, 2013
August 2003
Not Provided
  • Efficacy [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00070096 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Ixabepilone in Treating Patients With Advanced Cisplatin-Refractory Germ Cell Tumors
A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL

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.

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.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • Testicular Germ Cell Tumor
Drug: ixabepilone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
June 2007
Not Provided

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00070096
CDR0000329992, MSKCC-03041, NCI-6022
Not Provided
Not Provided
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Gnanamba V. Kondagunta, MD Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
April 2006

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