Phase IB-II, Open Label, Multicenter Feasibility Study of Pazopanib in Combination With Paclitaxel and Carboplatin in Patients With Platinum-Refractory/Resistant Ovarian, Fallopian Tube or Peritoneal Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 9
- 主要终点
- Progression-free survival according to RECIST 1.1 at 1 year (phase II)
研究概览
简要总结
RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of pazopanib hydrochloride when given together with paclitaxel and carboplatin in treating patients with refractory or resistant ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.
详细描述
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose of pazopanib hydrochloride in combination with paclitaxel and carboplatin in patients with platinum-refractory or -resistant ovarian epithelial, fallopian tube, or peritoneal carcinoma. (Phase I)
- To determine the progression-free survival (PFS) at 1 year according to the RECIST 1.1 in these patients. (Phase II)
Secondary
- To determine the safety and adverse event profiles in these patients. (Phase I and phase II)
- To determine the pharmacokinetics (PK) of this regimen using intensive sampling. (Phase I)
- To determine if there is PK interaction (and if so, what kind of PK interaction) between carboplatin and paclitaxel as well as pazopanib hydrochloride. (Phase I)
- To determine the response rate (RR) in these patients. (Phase I)
- To determine and evaluate predictive biomarkers. (Phase I and phase II)
- To determine the RR, overall survival (OS), and PFS of these patients. (Phase II)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
pazopanib in combination with paclitaxel and carboplatin
Phase I: Dose-escalation study of pazopanib in combination with paclitaxel and carboplatin given weekly in a group of patients with platinum-refractory or -resistant ovarian, fallopian tube or peritoneal carcinoma Phase II: Paclitaxel 30 mg/m² and Carboplatin 2.0 AUC weekly for 18 courses PLUS Pazopanib 400 mg daily
干预措施: carboplatin (Drug)
pazopanib in combination with paclitaxel and carboplatin
Phase I: Dose-escalation study of pazopanib in combination with paclitaxel and carboplatin given weekly in a group of patients with platinum-refractory or -resistant ovarian, fallopian tube or peritoneal carcinoma Phase II: Paclitaxel 30 mg/m² and Carboplatin 2.0 AUC weekly for 18 courses PLUS Pazopanib 400 mg daily
干预措施: paclitaxel (Drug)
pazopanib in combination with paclitaxel and carboplatin
Phase I: Dose-escalation study of pazopanib in combination with paclitaxel and carboplatin given weekly in a group of patients with platinum-refractory or -resistant ovarian, fallopian tube or peritoneal carcinoma Phase II: Paclitaxel 30 mg/m² and Carboplatin 2.0 AUC weekly for 18 courses PLUS Pazopanib 400 mg daily
干预措施: pazopanib hydrochloride (Drug)
pazopanib in combination with paclitaxel and carboplatin
Phase I: Dose-escalation study of pazopanib in combination with paclitaxel and carboplatin given weekly in a group of patients with platinum-refractory or -resistant ovarian, fallopian tube or peritoneal carcinoma Phase II: Paclitaxel 30 mg/m² and Carboplatin 2.0 AUC weekly for 18 courses PLUS Pazopanib 400 mg daily
干预措施: laboratory biomarker analysis (Other)
pazopanib in combination with paclitaxel and carboplatin
Phase I: Dose-escalation study of pazopanib in combination with paclitaxel and carboplatin given weekly in a group of patients with platinum-refractory or -resistant ovarian, fallopian tube or peritoneal carcinoma Phase II: Paclitaxel 30 mg/m² and Carboplatin 2.0 AUC weekly for 18 courses PLUS Pazopanib 400 mg daily
干预措施: pharmacological study (Other)
Paclitaxel and carboplatin only
Carboplatin AUC 2.7 and paclitaxel 60mg/m² weekly for 18 courses.
干预措施: carboplatin (Drug)
Paclitaxel and carboplatin only
Carboplatin AUC 2.7 and paclitaxel 60mg/m² weekly for 18 courses.
干预措施: paclitaxel (Drug)
Paclitaxel and carboplatin only
Carboplatin AUC 2.7 and paclitaxel 60mg/m² weekly for 18 courses.
干预措施: pazopanib hydrochloride (Drug)
结局指标
主要结局
Progression-free survival according to RECIST 1.1 at 1 year (phase II)
Maximum-tolerated dose of pazopanib hydrochloride, carboplatin, and paclitaxel (phase I)
次要结局
- Pharmacokinetics of pazopanib, carboplatin, and paclitaxel (phase I)
- Safety and tolerability according to CTCAE 4.0 (phase I and phase II)
- Predictive biomarkers (phase I and phase II)
- Age-related subanalysis for toxicity and efficacy (cut-off 65 years old) (phase II)
- Response rate (phase I and phase II)
- Overall survival (phase II)