Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Drugs used in chemotherapy, such as fenretinide, 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 fenretinide in treating patients who have recurrent or metastatic ovarian epithelial or primary peritoneal cancer.

Further Study Information

OBJECTIVES:

• Determine the efficacy of fenretinide in patients with recurrent or metastatic ovarian epithelial or primary peritoneal cancer.

• Determine the toxicity and pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to whether biopsy of disease is obtained for molecular determinants of response (yes vs no).

Patients receive oral fenretinide twice daily on days 1-7. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 27-40 patients will be accrued for this study within 1.5 years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed recurrent or metastatic ovarian epithelial or primary peritoneal cancer

• Measurable disease outside of previously irradiated field unless evidence of progression

• Received prior platinum- and paclitaxel-containing regimen

• No more than 2 prior chemotherapy regimens for recurrent disease (retreatment with initial chemotherapy regimen considered 1 regimen)

• No untreated or symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• SWOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count ≥1,500/mm^3

• Platelet count ≥ 100,000/mm^3

Hepatic:

• Bilirubin ≤ 2 times normal

• ALT or AST ≤ 3 times upper limit of normal (ULN)

Renal:

• Creatinine clearance ≥ 60 mL/min

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Fasting triglycerides no greater than ULN (may be normalized by antilipemic agent (e.g., atorvastatin or fenofibrate))

• No other malignancy within the past 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or other invasive malignancy in complete remission

• No other concurrent medical, psychological, or social condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic therapy directed at tumor

Chemotherapy:

• See Disease Characteristics

• At least 3 weeks since prior chemotherapy directed at tumor and recovered

• No prior fenretinide

• Prior isotretinoin, 9-cis-retinoic acid, or tretinoin allowed

Endocrine therapy:

• At least 3 weeks since prior endocrine therapy directed at tumor

Radiotherapy:

• See Disease Characteristics

• At least 3 weeks since prior radiotherapy directed at tumor and recovered

Surgery:

• At least 3 weeks since prior surgery for tumor and recovered

Other:

• At least 3 weeks since any other prior therapy directed at tumor

• No concurrent antioxidants (e.g., ascorbic acid or vitamin E)

Trial Contact Information

Trial Lead Organizations/Sponsors

California Cancer Consortium

Agustin Garcia

Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00026091
Information obtained from ClinicalTrials.gov on December 14, 2011

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