Ovarian Cancer Clinical Trial

Toremifene in Treating Patients With Ovarian Cancer

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.

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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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00003865

Recruitment Status:

Withdrawn

Sponsor:

George Washington University

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There is 1 Location for this study

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George Washington University Cancer Center
Washington, D.C. District of Columbia, 20037, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 2

Study ID:

NCT00003865

Recruitment Status:

Withdrawn

Sponsor:


George Washington University

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