Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer

Completed · Phase 2

Conditions studied: Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00617188

Run by

Masonic Cancer Center, University of Minnesota

People needed

26

Starts

2007-06-01

Expected to finish

2008-07-01

Last updated by the study team

2017-12-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Concurrent hormone replacement therapy
• Prior long-term anticoagulation therapy other than anti-platelet therapy

Where it is running

• Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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