Toremifene in Treating Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00003865
• Other study ID #: GWCC-7096
• Secondary ID: CDR0000067029NCI
• Status: Withdrawn
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 11, 2017
• Start date: July 22, 1999
• Est. completion date: February 22, 2017

Study information

• Verified date: July 2017
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 22, 2017
• Est. primary completion date: February 22, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• toremifene

Locations

Country	Name	City	State
United States	George Washington University Cancer Center	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States,