RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of 17-N-allylamino-17-demethoxygeldanamycin in treating patients who have recurrent advanced ovarian epithelial or primary peritoneal cavity cancer.

Condition	Treatment or Intervention	Phase
recurrent ovarian epithelial cancer peritoneal cavity cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer	Drug: 17-N-allylamino-17-demethoxygeldanamycin  Procedure: chemotherapy	Phase II

OBJECTIVES:

• 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).
• Determine the toxicity of this drug in these patients.
• 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.

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.

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm^3
• Platelet count ≥ 100,000/mm^3
• 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

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

Study chairs or principal investigators

Charles Erlichman, MD,  Study Chair,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000388036; MAYO-MC0362; NCI-6307
Record last reviewed:  September 2004
Record first received:  October 6, 2004
ClinicalTrials.gov Identifier:  NCT00093496
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-10-20