A Randomized Study Of Tamoxifen Versus Thalidomide (NSC# 66847) In Patients With Biochemical-Recurrence-Only Epithelial Ovarian Cancer, Cancer Of The Fallopian Tube, And Primary Peritoneal Carcinoma After First Line Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Median Progression-free Survival
研究概览
简要总结
Randomized phase III trial to compare the effectiveness of tamoxifen with that of thalidomide in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Estrogen can stimulate the growth of some types of cancer cells. Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known whether thalidomide is more effective than tamoxifen in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
详细描述
PRIMARY OBJECTIVES:
I. To compare the recurrence-free survival of women receiving tamoxifen or thalidomide for epithelial ovarian cancer, cancer of the fallopian tube, or primary peritoneal carcinoma who are in complete clinical remission following front-line treatment but have a high risk of recurrence due to rising serum CA-125.
II. To compare the toxicities and complications of these treatments.
SECONDARY OBJECTIVES:
I. To determine whether changes in serum biomarker levels including VEGF and/or bFGF are independent of the randomization treatment.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed stage III or IV ovarian epithelial, fallopian tube, or primary peritoneal cancer that was treated with only 1 prior first-line chemotherapy regimen (platinum/taxane-based)
- •Clinically and radiologically without evidence of measurable and nonmeasurable disease
- •Symptomatic ascites and pleural effusions are considered nonmeasurable disease
- •Must have a biochemical recurrence
- •CA 125 must have been normal prior to or normalized during first-line therapy and then subsequently rose to exceed twice the upper limit of normal
- •Patients entering study with a CA 125 level less than 100 U/mL must be confirmed a second time within a period of not more than 4 weeks
- •Patients with a CA 125 level of at least 100 U/mL may be entered without confirmatory measurement
- •Ineligible for a higher priority Gynecologic Oncology Group protocol (if one exists)
- •No history of brain metastases
- •Performance status - GOG 0-1
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •Creatinine clearance at least 60 mL/min
- •No history of deep venous thrombosis
- •No prior cerebrovascular accident
- •No history of pulmonary embolism
- •No significant infection
- •No grade 2 or greater sensory or motor neuropathy
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use at least 1 highly active method and at least 1 additional effective method of contraception for 4 weeks before, during, and for 4 weeks after study participation
- •No prior immunotherapy (e.g., interleukins)
- •No prior biological response modifiers (e.g., monoclonal antibodies)
- •No prior antiangiogenic agents (e.g., carbonic anhydrase inhibitors)
- •At least 3 weeks since prior anticancer chemotherapy and recovered
- •No prior or concurrent tamoxifen or other selective estrogen receptor modulators
- •At least 4 weeks since prior and no concurrent hormones (e.g., estrogen or progesterone)
- •At least 3 weeks since prior anticancer radiotherapy and recovered
- •At least 3 weeks since prior anticancer surgery and recovered
- •Prior second-look surgery without cytoreduction allowed
- •At least 3 weeks since other prior anticancer therapy and recovered
- •No prior interval cytoreduction
- •No concurrent full-dose therapeutic anticoagulation
- •No concurrent antiseizure medications for seizure disorder
- •No concurrent bisphosphonates (e.g., zoledronate)
排除标准
- 未提供
研究组 & 干预措施
Arm I (thalidomide)
Patients receive oral thalidomide once daily on days 1-28.
干预措施: thalidomide (Drug)
Arm I (thalidomide)
Patients receive oral thalidomide once daily on days 1-28.
干预措施: laboratory biomarker analysis (Other)
Arm II (tamoxifen)
Patients receive oral tamoxifen twice daily on days 1-28.
干预措施: tamoxifen citrate (Drug)
Arm II (tamoxifen)
Patients receive oral tamoxifen twice daily on days 1-28.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Median Progression-free Survival
时间窗: from enrollment onto the study until first disease progression or death due to any cause
次要结局
未报告次要终点