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Toremifene in Treating Patients With Ovarian Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT00003865
First received: November 1, 1999
Last updated: July 11, 2017
Last verified: July 2017
  Purpose

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 Intervention Phase
Ovarian Cancer Drug: toremifene Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by George Washington University:

Enrollment: 0
Actual Study Start Date: July 22, 1999
Study Completion Date: February 22, 2017
Primary Completion Date: February 22, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Toremifene
All enrolled patients
Drug: toremifene

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.

  Eligibility

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003865

Locations
United States, District of Columbia
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
  More Information

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT00003865     History of Changes
Other Study ID Numbers: GWCC-7096
CDR0000067029 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-V99-1540
Study First Received: November 1, 1999
Last Updated: July 11, 2017
Individual Participant Data (IPD) Sharing Statement:
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
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Toremifene
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 21, 2017