Overview

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Withdrawn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