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Toremifene in Treating Patients With Ovarian Cancer

This study has been completed.

Sponsored by: George Washington University
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003865
  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 II

MedlinePlus related topics:   Cancer    Ovarian Cancer   

ChemIDplus related topics:   Toremifene    Toremifene citrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Active Control
Official Title:   Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   July 1999

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: A total of 60 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders 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

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

Locations
United States, District of Columbia
George Washington University Cancer Center    
      Washington, District of Columbia, United States, 20037

Sponsors and Collaborators
George Washington University

Investigators
Study Chair:     James D. Ahlgren, MD     George Washington University    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000067029, GWCC-7096, NCI-V99-1540
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00003865
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent ovarian epithelial cancer  
ovarian serous cystadenocarcinoma  

Study placed in the following topic categories:
Cystadenocarcinoma, Serous
Ovarian cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian epithelial cancer
Toremifene
Recurrence
Carcinoma
Genital Diseases, Female
Carcinoma, Papillary
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Pharmacologic Actions
Adnexal Diseases
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2008




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