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Toremifene in Treating Patients With Ovarian Cancer



Toremifene in Treating Patients With Ovarian Cancer

For Condition: recurrent ovarian epithelial cancer,ovarian serous cystadenocarcinoma
Status: Completed
Sponsor(s): George Washington University ,
Synopsis: 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.
Details: 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:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
JamesAhlgren,  Study Chair,  George Washington University

George Washington University Cancer Center
Washington D.C.,  District of Columbia,  20037
United States
 


Additional Information:
Study ID Numbers:  CDR0000067029;  GWCC-7096,NCI-V99-1540
Study Start Date: 
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003865

Other Recurrent Ovarian Epithelial Cancer Studies:
1. Tamoxifen Compared With Thalidomide in Treating Women With Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

2. Platinum-based Chemotherapy With or Without Paclitaxel in Treating Patients With Relapsed Ovarian Cancer

3. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer

4. Cisplatin and Flavopiridol in Treating Patients With Advanced Ovarian Epithelial Cancer or Primary Peritoneal Cancer

5. Gene Therapy in Treating Patients With Advanced Recurrent or Persistent Ovarian Cancer or Primary Peritoneal Cancer

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