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

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

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

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

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