Clinical trial · Interventional
Hormone Therapy With Arzoxifene Hydrochloride in Treating Women With Metastatic Refractory Ovarian Cancer or Primary Peritoneal Cancer
Phase II Study of LY353381-HC1 Administered to Women With Refractory Ovarian Cancer
NCT00003670CI-TRIAL-00007111completedPhase 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 arzoxifene hydrochloride may fight ovarian or peritoneal cancer by blocking the use of estrogen by the tumor cells. PURPOSE: This phase II trial is studying how well arzoxifene hydrochloride works in treating women with metastatic refractory ovarian cancer or primary peritoneal cancer.
Conditions
Conditions (2)
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 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arzoxifene hydrochloride | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed metastatic refractory ovarian epithelial cancer OR primary peritoneal cancer provided the clinical and pathological features of the tumor are similar to primary ovarian epithelial carcinoma Patients must have received prior chemotherapy including at least one platinum analogue and one taxane analogue unless patient is poor candidate for these treatments due to neuropathy, nephropathy, or hypersensitivity (to Taxol only) Bidimensionally measurable disease by x-ray, CT scan, MRI, or physical exam Ascites not considered measurable or evaluable Hormone receptor status: Estrogen receptor status must be known or tissue must be available for analysis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Sex: Female Menopausal status: Not specified Life expectancy: At least 24 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL (transfusion-independent) Prothrombin time or activated partial thromboplastin time no greater than 1.25 times upper limit of normal (ULN) Hepatic: Bilirubin no greater than 1.5 times normal ALT or AST no greater than 2.5 times ULN (ALT and AST no greater than 5 times ULN in the presence of liver metastases) Renal: Creatinine no greater than 1.5 ULN Other: No other malignancy within the past 5 years except adequately treated nonmelanomatous cancer of the skin or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than 2 prior chemotherapy regimens (including repeated drug combinations) for patients with potentially platinum-sensitive disease No more than 3 prior chemotherapy regimens (including repeated drug combinations) for patients with platinum resistant disease At least 6 weeks since mitomycin or nitrosoureas At least 3 weeks since other prior chemotherapy Recovered from prior chemotherapy Endocrine therapy: At least 3 weeks since hormone replacement therapy No prior hormonal therapy for ovarian cancer Radiotherapy: At least 2 weeks since prior radiotherapy and recovered Surgery: Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.