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Toremifene in Treating Patients With Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003865
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: December 2003

November 1, 1999
July 23, 2008
July 1999
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Complete list of historical versions of study NCT00003865 on ClinicalTrials.gov Archive Site
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Toremifene in Treating Patients With Ovarian Cancer
Phase II Study of Two Dose Levels of Toremifene in the Treatment of Chemotherapy-Resistant Papillary Carcinoma of the Ovary

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.

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.

Interventional
Phase 2
Allocation: Randomized
Primary Purpose: Treatment
Ovarian Cancer
Drug: toremifene
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003865
CDR0000067029, GWCC-7096, NCI-V99-1540
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George Washington University
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Study Chair: James D. Ahlgren, MD George Washington University
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP