Status:
COMPLETED
Fulvestrant in Treating Patients With Recurrent Ovarian Epithelial Cancer
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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: Th...
Detailed Description
OBJECTIVES: Primary * To determine the 90-day clinical benefit (defined as the sum of complete responses, partial responses, and stable disease) in patients with recurrent ovarian epithelial cancer ...
Eligibility Criteria
Inclusion
- 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
- Concurrent hormone replacement therapy
- Prior long-term anticoagulation therapy other than anti-platelet therapy
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00617188
Start Date
June 1 2007
End Date
July 1 2008
Last Update
December 28 2017
Active Locations (1)
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1
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455