Phase 2
N=26
Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer
Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00617188 ↗Enrolled (actual)
26
Serious AEs
38.5%
Results posted
Mar 2010
Primary outcome: Primary: Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) — 8; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fulvestrant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST) |
8; 18 | — |
| SECONDARY Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin) |
13; 13 | — |
| SECONDARY Median Number of Days to Treatment Termination |
62 | — |
| SECONDARY Mean Scores - Quality of Life Assessment |
87; 84; 81 | — |
| SECONDARY Serum Skeletal-Specific Alkaline Phosphatase Concentration |
14.0; 16.1; 18.5; 16.2 | — |
| SECONDARY Urine N-telopeptide Concentration |
50; 49; 43; 46 | — |
Summary
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.
Eligibility Criteria
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 ( 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 therapy
Data sourced from ClinicalTrials.gov (NCT00617188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.