A Dose Escalation Phase II Study of Sunitinib Plus Erlotinib in Advanced Renal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.
研究概览
简要总结
RATIONALE: Sunitinib and erlotinib may stop the growth of tumor cell by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying the best dose of erlotinib when given together with sunitinib and to see how well they work in treating patients with unresectable or metastatic kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of erlotinib hydrochloride when administered with sunitinib malate in patients with unresectable or metastatic renal cell carcinoma.
- Determine the 8-month progression-free survival of patients treated with this regimen.
Secondary
- Determine the safety of sunitinib malate and erlotinib hydrochloride in these patients.
- Determine the duration of response in these patients.
- Determine the proportion of patients whose best overall response is complete response, partial response, stable disease, or progressive disease.
- Determine the overall survival of patients treated with this regimen.
- Determine the maximum percent reduction in tumor measurement in patients treated with this regimen.
- Collect blood and tissue from these patients for future correlative studies.
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
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Erlotinib and Sunitinib
Drug: erlotinib hydrochloride Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
- 100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
- 150 mg/day, continuous daily
Drug: sunitinib malate Will be administered at 50 mg daily, 4 weeks on, 2 weeks off
干预措施: sunitinib malate (Drug)
Erlotinib and Sunitinib
Drug: erlotinib hydrochloride Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
- 100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
- 150 mg/day, continuous daily
Drug: sunitinib malate Will be administered at 50 mg daily, 4 weeks on, 2 weeks off
干预措施: erlotinib hydrochloride (Drug)
Erlotinib and Sunitinib
Drug: erlotinib hydrochloride Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;
- 100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;
- 150 mg/day, continuous daily
Drug: sunitinib malate Will be administered at 50 mg daily, 4 weeks on, 2 weeks off
干预措施: biopsy (Procedure)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Erlotinib Hydrochloride When Used in Combination With Sunitinib.
时间窗: Participants assessed for DLTs weekly during the first cycle of treatment and every 3 weeks in subsequent cycles until at least one DLT occurs in 33% or more of participants at that dose; participants assessed for the duration of the study, up to 7 years
The MTD is defined as the dose that produces dose limiting toxicity (DLT) in 33% of the patients.
Progression-free Survival at 8 Months
时间窗: 8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney
Defined as the proportion of patients who are progression free (CR, PR and SD) at 8 months after initiating treatment with sunitinib in combination with erlotinib in patients with metastatic or unresectable clear cell or papillary carcinoma of the kidney. Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (20% increase in the sum).
次要结局
- Median Time to Progression(For the duration of the study, up to 7 years)
- Proportion of Patients Whose Best Overall Response is Complete Response, Partial Response, Stable Disease, or Progressive Disease(From the start of treatment until the criteria for response is met.)
- To Determine the Safety of Sunitinib in Combination With Erlotinib(For the duration of the study, up to 7 years)
- Maximum Percent Change in Tumor Measurement(Baseline through end of study, up to 7 years)
研究者
Christopher Ryan
Principal Investigator
OHSU Knight Cancer Institute