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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Phase 2

Conditions: Brain and Central Nervous System Tumors; Extragonadal Germ Cell Tumor; Ovarian Cancer; Testicular Germ Cell Tumor

Treatments: Drug: ixabepilone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00070096

MSKCC-03041

CDR0000329992

NCI-6022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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