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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Study of BMS-247550 In Advanced Germ Cell Tumor Patients - THERAPEUTIC/DIAGNOSTIC PROTOCOL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00070096
• Other study ID #: CDR0000329992
• Secondary ID: MSKCC-03041NCI-6
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2003
• Last updated: June 21, 2013
• Start date: August 2003
• Est. completion date: June 2007

Study information

• Verified date: April 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Extragonadal Germ Cell Tumor
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Nervous System Neoplasms
• Ovarian Cancer
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Drug:
• ixabepilone

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy			No
Primary	Safety			Yes