A Phase II, Double-Blinded, Randomized Evaluation of Femara (Letrozole) Versus Placebo for Adjuvant Treatment After Completion of First-Line Chemotherapy for Patients With Optimally Debulked and Chemoresponsive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Median Progression-free survival (PFS): Time to progression or death from complete response (CR)
研究概览
简要总结
Primary Objective:
- Evaluate the efficacy of letrozole to increase the duration of progression-free survival (defined as time to earliest occurrence of local or distant recurrence or clinically significant elevation in CA-125) when used as adjuvant treatment after completion of primary surgery and first line platinum containing chemotherapy in patients with optimally debulked (< 1 cm residual disease) stage IIA-IIIC ovarian, fallopian tube, or primary peritoneal cancer.
Secondary Objective:
- Observe the incidence of local and distant recurrences.
详细描述
THE STUDY DRUG:
Letrozole is designed to block the enzyme that makes estrogen in post-menopausal women. By interfering with the production of estrogen made by the enzyme, letrozole decreases the total amount of estrogen in the body. As a result, less estrogen can reach cancer cells, which may prevent their growth.
SCREENING TESTS:
Before you can begin taking the study drug on this study, you will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- Your complete medical history will be recorded.
- You will have a physical exam, including a pelvic exam and measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
- Blood (about 2-3 teaspoons) will be drawn for routine tests and to test for tumor markers.
- You will have a chest x-ray and a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan to check the status of the disease.
- Your previously collected tumor tissue, if available, will be tested to learn if the estrogen receptor is positive or negative.
- You will be asked how well you are able to perform the normal activities of daily living (performance status evaluation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with optimally debulked (< 1 cm residual disease) stage IIA-IIIC ovarian, fallopian tube, or primary peritoneal cancer that have achieved a complete clinical response (CR) to first-line surgery and chemotherapy.
- •All patients must have had appropriate surgery with appropriate tissue available for histologic evaluation to confirm diagnosis and stage.
- •Patients must have completed primary treatment within the past 8 weeks and received at least 5 cycles and not more than 8 cycles of a platinum (IV or IP) and paclitaxel or docetaxel-based combination chemotherapy. Patients must have no symptoms suggestive of persistent cancer.
- •Patient must have a CT or MRI scan of the abdomen/pelvis with no evidence of metastatic disease and a normal CA-125 (< 35 Units/mL) following primary therapy.
- •Patients willing to sign informed consent to participate in study for 5 years or until first recurrence.
排除标准
- •Patients with any evidence of metastatic disease after completion of surgery and first line chemotherapy
- •Patients with low grade ovarian cancer histology.
- •If chemotherapy initiated greater than 8 weeks after primary surgery or completed more than 8 weeks prior to treatment start.
- •Patients that received neoadjuvant chemotherapy.
- •Patients taking any form of HRT and/or CAM products (i.e. phytoestrogens, etc.)
- •Patients with history of prothrombic clotting disorders (i.e PE or DVT).
- •Patients with history of malignant disease within past 10 years except for squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
- •Patients with severe concomitant disease which would place patient at unusual risk or confound the results of the trial.
研究组 & 干预措施
Femara
干预措施: Femara (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Median Progression-free survival (PFS): Time to progression or death from complete response (CR)
时间窗: Assessed after 12 weeks of therapy, and followed for 36 months post-treatment
PFS defined as time to earliest occurrence of local or distant recurrence or clinically significant elevation in CA-125. Biochemical progression is defined as two serially rising serum values of CA-125 greater than or equal to two times the upper limits of normal (ULN \>35 U/ML) performed at least one week apart, regardless of CT scan results.
次要结局
未报告次要终点