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Toremifene in Treating Patients With Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
toremifene
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring recurrent ovarian epithelial cancer, ovarian serous cystadenocarcinoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • George Washington University Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Toremifene

Arm Description

All enrolled patients

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 11, 2017
Sponsor
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT00003865
Brief Title
Toremifene in Treating Patients With Ovarian Cancer
Official Title
Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Study Start Date
July 22, 1999 (Actual)
Primary Completion Date
February 22, 2017 (Actual)
Study Completion Date
February 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
George Washington University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
recurrent ovarian epithelial cancer, ovarian serous cystadenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toremifene
Arm Type
Experimental
Arm Description
All enrolled patients
Intervention Type
Drug
Intervention Name(s)
toremifene

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James D. Ahlgren, MD
Organizational Affiliation
George Washington University
Official's Role
Study Chair
Facility Information:
Facility Name
George Washington University Cancer Center
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Toremifene in Treating Patients With Ovarian Cancer

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