Toremifene in Treating Patients With Ovarian Cancer

George Washington University (GW)

Status and phase

Withdrawn

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: toremifene

Study type

Interventional

Funder types

Other

Identifiers

NCT00003865

CDR0000067029 (Registry Identifier)

NCI-V99-1540

GWCC-7096

Details and patient eligibility

About

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.

Full description

OBJECTIVES:

Determine the effects of toremifene in terms of response rate, duration of response, duration of survival, and toxicity in patients with chemotherapy resistant papillary carcinoma of the ovary.
Assess whether a dose response effect is likely for this regimen in these patients.
Assess quality of life of these patients.

OUTLINE: This is a randomized study.

Patients receive one of two doses of oral toremifene daily for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed before therapy and then every 4 weeks during therapy.

Patients are followed every 12 weeks until death.

PROJECTED ACCRUAL: The study was closed before any patient accrual.

Sex

Female

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: