A Phase II Trial Of BAY 43-9006, A Novel Raf Kinase Inhibitor Plus Paclitaxel/Carboplatin In Women With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Or Fallopian Tube Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 5
- 主要终点
- Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
研究概览
简要总结
Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib together with chemotherapy may kill more tumor cells. This randomized phase II trial is studying how well giving sorafenib together with paclitaxel and carboplatin works in treating patients with recurrent ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. (Sorafenib only group closed as of 10/10/2008).
详细描述
PRIMARY OBJECTIVES :
I. Compare the progression-free and overall survival rate of patients with recurrent platinum-sensitive ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with sorafenib with or without carboplatin and paclitaxel. (Arm I [sorafenib only] closed to accrual 10/01/2008) II. Evaluate the response rate and time to disease progression in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to performance status and participating center.
ARM I (closed to accrual 10/01/2008): Patients receive oral sorafenib twice daily on days 1-28.Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II.
ARM II: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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
- 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
- •Diagnosis of ovarian epithelial, primary peritoneal, or fallopian tube cancer
- •Recurrent disease
- •Must have received a prior platinum-based regimen
- •Platinum-sensitive (treatment-free interval > 6 months)
- •No more than 2 prior chemotherapy regimens
- •Measurable disease
- •At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- •Not in a prior irradiation field
- •No known brain metastases
- •Performance status:
- •ECOG 0-2 OR
- •Karnofsky 80-100%
- •Life expectancy:
- •More than 12 weeks
- •Hematopoietic:
- •Absolute neutrophil count >= 1,500/mm3
- •Platelet count >= 100,000/mm3
- •Hemoglobin >= 9 g/dL
- •No bleeding diathesis
- •Bilirubin < 1.5 times upper limit of normal (ULN)
- •AST or ALT =< 2 times ULN
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other agents used in the study
- •Patients who have had a reaction to a taxane or a platinum and have not yet been rechallenged may undergo a desensitization regimen on study
- •No hypersensitivity to paclitaxel or drugs using the vehicle Cremophor El:
- •Prior hypersensitivity reaction to paclitaxel allowed provided rechallenged successfully
- •Creatinine < 2 mg/dL
- •Cardiovascular:
- •Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed if stable for the past 6 months
- •No symptomatic congestive heart failure
- •No uncontrolled hypertension
- •No cardiac arrhythmia
- •No unstable angina pectoris;
- •No myocardial infarction within the past 6 months
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Adequate intestinal function
- •No concurrent requirements for IV hydration or nutritional support
- •No active or ongoing infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No other concurrent uncontrolled illness
- •No other invasive malignancy with the past 5 years except nonmelanoma skin cancer
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •More than 3 weeks since prior hormonal therapy
- •More than 4 weeks since prior radiotherapy and recovered
- •No prior sorafenib
- •No prior anticancer therapy that contraindicates study therapy
- •No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (phenytoin, carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort)
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No concurrent therapeutic anticoagulation therapy
- •Concurrent prophylactic low-dose warfarin allowed for maintenance of venous or arterial access devices
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm I (closed to accrual 10/10/2008)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
干预措施: Sorafenib Tosylate (Drug)
Arm II
Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Carboplatin (Drug)
Arm II
Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Paclitaxel (Drug)
Arm II
Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: Sorafenib Tosylate (Drug)
结局指标
主要结局
Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
时间窗: after 6 weeks (2 cycles)
Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.
次要结局
- Evaluate the Progression-free Survival Rate(up to 85 months of follow-up)
- Overall Survival(up to 85 months of follow-up)