Toremifene in Treating Patients With Ovarian Cancer

• Status: Withdrawn
• Trial end date: 2017-02-22
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Estrogen can stimulate the growth of ovarian cancer cells. Hormone therapy using toremifene may fight ovarian cancer by reducing the production of estrogen.

PURPOSE: Randomized phase II trial to study the effectiveness of toremifene in treating patients who have recurrent or refractory ovarian cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: George Washington University
• Treatments: Toremifene

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed serous papillary carcinoma of the ovary

• Recurrent or refractory disease following at least one regimen including paclitaxel, cisplatin, or carboplatin

• Measurable disease outside of irradiated field

• No CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Zubrod 0-2

Life expectancy:

• At least 16 weeks

Hematopoietic:

• Absolute neutrophil count at least 1,800/mm^3

• Platelet count at least 125,000/mm^3

• No history of thrombosis or thromboembolic events

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 2 months after study

• No other concurrent second malignancy or prior malignancy within past 5 years, except basal or squamous cell skin cancer or curatively treated stage I carcinoma of the cervix

• No concurrent infection

• At least 3 days since prior fever (unless due to tumor)

• No other concurrent severe medical illness

• No HIV positivity

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No concurrent chemotherapy

Endocrine therapy:

• No prior tamoxifen or antiestrogen therapy

Radiotherapy:

• See Disease Characteristics

• At least 6 months since prior radiotherapy

• No concurrent radiotherapy except to symptomatic or potentially disabling bone lesion accompanied by other measurable disease

Surgery:

• Not specified

Other:

• No concurrent anticoagulants

• No other concurrent therapeutic trials