Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer
Condition: Ovarian Cancer
Intervention: Fulvestrant
Intervention description: Fulvestrant, 500 milligrams (mg) intramuscularly (IM) on Day 1, 250 mg IM on Day 15, and 250 mg IM on Day 29 and every 28 days thereafter until either intolerance or disease progression.
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent ovarian epithelial cancer

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 (<) 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