Clinical trial NCT00617188 (phase 2, status: completed)
Conditions: ovarian cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: fulvestrant
SMILES: [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=CC=C(O)C=C3C[C@@H](CCCCCCCCCS(=O)CCCC(F)(F)C(F)(F)F)[C@@]21[H]
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 (<) 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 therapy