Clinical trial · Interventional
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
NCT00003865CI-TRIAL-00028613withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| toremifene | Drug | Toremifene | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Toremifene
- description
- All enrolled patients
- interventionNames
- Drug: toremifene
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.