Toremifene in Treating Patients With Ovarian Cancer
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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: | Allocation: Randomized 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 |
| Study Start Date: | July 1999 |
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 |
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| United States, District of Columbia | |
| George Washington University Cancer Center | |
| Washington, District of Columbia, United States, 20037 | |
| Study Chair: | James D. Ahlgren, MD | George Washington University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00003865 History of Changes |
| Other Study ID Numbers: | CDR0000067029, GWCC-7096, NCI-V99-1540 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent ovarian epithelial cancer ovarian serous cystadenocarcinoma |
Additional relevant MeSH terms:
|
Carcinoma, Papillary Ovarian Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Toremifene Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions 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 May 21, 2013