NCT00617188已完成2 期
Phase II Trial of Fulvestrant in Treatment of Recurrent Ovarian Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
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.
详细描述
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 treated with single agent fulvestrant.
Secondary
- To establish the time to termination of treatment (due to all causes including progression and intolerance) for patients treated with this drug.
- To describe the toxicities observed in patients treated with this drug.
- To evaluate the quality of life of patients treated with this drug.
- To determine the effect that prolonged estrogen receptor antagonism has on markers of bone mineral turnover.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Concurrent hormone replacement therapy
- •Prior long-term anticoagulation therapy other than anti-platelet therapy
研究组 & 干预措施
Fulvestrant
Experimental
Fulvestrant 500 milligrams (mg) Day 1; 250 mg Day 1, 29 and every 28 days thereafter.
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Patients' Overall 90-Day Clinical Response as Measured by Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: Day 90
Best response recorded from the start of treatment until Day 90. Defined by the sum of the Complete Responses (CR), Partial Responses (PR) and Stable Disease (SD) in patients treated with fulvestrant. CR=disappearance of all lesions, PR=\>or =30% decrease in sum of all target lesions, Progressive Disease (PD) =\>or=20% increase in sum of all target or any new lesions, SD=not CR, PR or PD.
次要结局
- Urine N-telopeptide Concentration(Baseline, 1 Month, 3 Months, 6 Months)
- Patients' Overall 90-Day Clinical Response as Measured by Modified Response Evaluation Criteria in Solid Tumors (Rustin)(Day 90)
- Median Number of Days to Treatment Termination(Up to 373 Days)
- Mean Scores - Quality of Life Assessment(Baseline, 3 Months Post Treatment, 6 Months Post Treatment)
- Serum Skeletal-Specific Alkaline Phosphatase Concentration(Baseline, 1 Month, 3 Months, 6 Months)
研究者
研究点 (1)
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