Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Estradiol; Fulvestrant

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