Clinical trial · Interventional
Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer
Phase II Trial of Fulvestrant in Treatment of Recurrent Ovarian Carcinoma
NCT00617188CI-TRIAL-00030923completedPhase 2Results postedClinicalTrials.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 cause the growth of ovarian epithelial cancer cells. Hormone therapy using fulvestrant may fight ovarian cancer by blocking the use of estrogen by the tumor cells. PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with recurrent ovarian epithelial 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 |
|---|---|---|---|
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fulvestrant
- description
- Fulvestrant 500 milligrams (mg) Day 1; 250 mg Day 1, 29 and every 28 days thereafter.
- interventionNames
- Drug: Fulvestrant
Primary outcomes (1)
- measure
- Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
- timeFrame
- Day 90
- description
- Best response recorded from the start of treatment until Day 90. Defined by the sum of the Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=disappearance of all lesions, PR=\>or =30% decrease in sum of all target lesions, Progressive Disease (PD) =\>or=20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically confirmed ovarian epithelial carcinoma
* Recurrent or persistent disease
* Must have received greater than or equal to (≥) 2 prior cytotoxic chemotherapy regimens, including ≥ 1 platinum-containing regimen
* Disease not amenable to curative treatment with surgery and/or radiotherapy
* Must have measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) and/or a serum cancer antigen 125 (CA-125) level that is rising and meets 1 of the following criteria:
* Serum CA-125 level greater than (\>) upper limit of normal (typically 35 μ/mL) on two evaluations at least 2 weeks apart
* Serum CA-125 level less than (\<) 35 μ/mL but has risen progressively \> 200% over successive specimens ≥ 2 weeks apart
* Estrogen receptor-positive tumor
* Gynecologic Oncology Group (GOG) performance status 0-3
* Platelet count ≥ 50 x 10\^9/Liter
* Serum creatinine less than or equal to (≤) 2.5 mg/deciliter
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Serum glutamic oxaloacetic transaminase (SGOT) ≤ 3 times upper limit of normal (ULN)
* alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
* Alkaline phosphatase ≤ 3 times ULN
* Prothrombin time-International Normalized Ratio (INR) ≤ 1.6
* Not pregnant or nursing
* Negative pregnancy test
* Must be sterile or fertile patients must use effective contraception (i.e., double method including ≥ 1 barrier, injectable, implantable, condoms plus spermicide)
* Prior malignancy allowed provided the patient has been disease-free for ≥ 5 years
* Patients with previously diagnosed basal cell skin cancer are eligible immediately after completing therapy
* No history of bleeding (i.e., disseminated intravascular coagulation or clotting factor deficiency)
* No documented sensitivity to active or inactive excipients of fulvestrant (i.e., castor oil or mannitol)
* Recovered from the effects of prior surgery, radiotherapy, and/or chemoradiotherapy
* At least 3 weeks since prior chemotherapy
* At least 3 weeks since prior complete radiotherapy regimen alone or chemoradiotherapy
* An incomplete radiotherapy regimen (\< 500 Gray) is allowed within the 3-week time frame
Exclusion Criteria:
* Concurrent hormone replacement therapy
* Prior long-term anticoagulation therapy other than anti-platelet therapyReferences
Publications (1)
- RESULTArgenta PA, Thomas SG, Judson PL, Downs LS Jr, Geller MA, Carson LF, Jonson AL, Ghebre R. A phase II study of fulvestrant in the treatment of multiply-recurrent epithelial ovarian cancer. Gynecol Oncol. 2009 May;113(2):205-9. doi: 10.1016/j.ygyno.2009.01.012. Epub 2009 Feb 23. PMID 19239974