Toremifene in Treating Patients With Ovarian Cancer

NCT00003865 | Withdrawn Phase 2

• 3 other identifiers: GWCC-7096CDR0000067029NCI-V99-1540
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

recurrent ovarian epithelial cancer; ovarian serous cystadenocarcinoma

Study Arms (1)

Toremifene

EXPERIMENTAL

All enrolled patients

Drug: toremifene

Interventions

toremifene DRUG

Toremifene

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University Cancer Center

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Toremifene

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• James D. Ahlgren, MD

  George Washington University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: July 22, 1999
• Primary Completion: February 22, 2017
• Study Completion: February 22, 2017
• Last Updated: July 13, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)