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Toremifene in Treating Patients With Ovarian Cancer

Sponsor
George Washington University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00003865
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
211.1
Actual Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary
Actual Study Start Date :
Jul 22, 1999
Actual Primary Completion Date :
Feb 22, 2017
Actual Study Completion Date :
Feb 22, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Toremifene

All enrolled patients

Drug: toremifene

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 George Washington University Cancer Center Washington, D.C. District of Columbia United States 20037

    Sponsors and Collaborators

    • George Washington University

    Investigators

    • Study Chair: James D. Ahlgren, MD, George Washington University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    George Washington University
    ClinicalTrials.gov Identifier:
    NCT00003865
    Other Study ID Numbers:
    • GWCC-7096
    • CDR0000067029
    • NCI-V99-1540
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jul 13, 2017
    Last Verified:
    Jul 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by George Washington University
    recurrent ovarian epithelial cancer
    ovarian serous cystadenocarcinoma
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial
    Toremifene

    Study Results

    No Results Posted as of Jul 13, 2017