Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Fenretinide in Treating Patients With Recurrent or Metastatic Ovarian Epithelial or Primary Peritoneal Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI CCC-PHII-25 LAC-USC-5GYN003, NCI-19, 19, NCT00026091

Objectives

1. Determine the efficacy of fenretinide in patients with recurrent or metastatic ovarian epithelial or primary peritoneal cancer.
2. Determine the toxicity and pharmacokinetics of this drug in these patients.

Entry 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

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)

Patient Characteristics:

Age:

• 18 and over

Performance status:

• SWOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count ≥1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

California Cancer Consortium

Agustin Garcia, MD, Protocol chair(Contact information may not be current)		Ph: 310-600-8400 Email: agarcia@premiereoncology.com

Registry Information
Official Title		Phase II Trial Of Fenretinide (NSC 374551) In Recurrent Ovarian Cancer And Primary Peritoneal Carcinoma
Trial Start Date		2001-11-09
Registered in ClinicalTrials.gov		NCT00026091
Date Submitted to PDQ		2001-08-29
Information Last Verified		2004-04-09
NCI Grant/Contract Number		N01-CM17101, P30-CA14089

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