Toremifene in Treating Patients With Ovarian Cancer

NCT ID: NCT00003865

Last Updated: 2017-07-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-07-22
• Study Completion Date: 2017-02-22

Brief 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.

Detailed 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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Toremifene

All enrolled patients

Group Type: EXPERIMENTAL

toremifene

Intervention Type: DRUG

Interventions

toremifene

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James D. Ahlgren, MD

Role: STUDY_CHAIR

George Washington University

Locations

George Washington University Cancer Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

CDR0000067029

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-V99-1540

Identifier Type: -

Identifier Source: secondary_id

GWCC-7096

Identifier Type: -

Identifier Source: org_study_id