Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Recurrent Advanced Ovarian Epithelial or Peritoneal Cavity Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Temporarily closed 18 and over NCI MAYO-MC0362 NCI-6307

Objectives

1. Determine the response rate, time to progression, and survival of patients with recurrent advanced ovarian epithelial or primary peritoneal cavity cancer treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG).
2. Determine the toxicity of this drug in these patients.
3. Correlate the effect of this drug on chaperone and client proteins in tumor samples and peripheral blood mononuclear cells with response, time to progression, and survival of these patients.

Entry Criteria

Disease Characteristics:

• Diagnosis of ovarian epithelial or primary peritoneal cavity cancer
  • Advanced disease
  • Recurrent disease



• Platinum-resistant disease, defined as 1 of the following:
  • Failure to respond to initial platinum therapy
  • Recurrence < 6 months after completing a platinum-containing regimen
  • Failure to respond to a platinum-containing regimen during retreatment after an initial response



• Measurable or evaluable disease
  • Patients with a rising CA 125 level, even in the absence of other indicators of disease, allowed provided CA 125 is ≥ 2 times upper limit of normal (ULN)



• Patients with accessible disease must be willing to undergo tumor biopsies



• No CNS metastases

Prior/Concurrent Therapy:

Biologic therapy

• More than 4 weeks since prior immunotherapy
• More than 4 weeks since prior biologic therapy
• No concurrent immunotherapy
• No concurrent routine or prophylactic colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])

Chemotherapy

• See Disease Characteristics
• More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
• No other concurrent chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy to > 25% of bone marrow
• More than 4 weeks since prior radiotherapy
• More than 4 weeks since prior radiopharmaceuticals
• No concurrent radiotherapy

Surgery

• Not specified

Other

• No other concurrent investigational therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL

Hepatic

• Bilirubin normal
• Alkaline phosphatase ≤ 2.5 times ULN
• AST ≤ 2.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No New York Heart Association class III or IV heart disease

Other

• No seizure disorder
• No uncontrolled infection
• No history of serious allergic reaction to eggs

Projected Accrual

A total of 12-40 patients will be accrued for this study within 8-24 months.

Outline

This is a multicenter study.

Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

Charles Erlichman, MD, Protocol chair		Ph: 507-284-2511 Email: erlichman.charles@mayo.edu

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