Ovarian Cancer Clinical Trial
Official title:
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
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.
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) OUTLINE: This is a multicenter, phase I, dose-escalation study of carboplatin, paclitaxel, and pazopanib hydrochloride followed by a phase II randomized study. - Phase I: Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on day 1. Patients also receive oral pazopanib hydrochloride* once daily on days 2-7. Treatment repeats every week for up to 18 courses**. Patients then continue to receive oral pazopanib hydrochloride once daily in the absence of disease progression or unacceptable toxicity. NOTE: *Pazopanib hydrochloride is started in course 2 in order to evaluate the pharmacokinetic of paclitaxel and carboplatin prior to pazopanib hydrochloride administration. - Phase II: Patients are stratified according to center, disease status (platinum-refractory vs -resistant) and number of prior lines of treatment (1 vs more than 1). Patients are randomized in a 2:1 ratio (arm II [experimental arm]: arm I [standard arm]) to 1 of 2 treatment arms. - Arm I (standard arm): Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every week for up to 18 courses. - Arm II (experimental arm): Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Patients also receive oral pazopanib hydrochloride once daily on days 2-7. Treatment repeats every week for up to 18 courses**. Patients then continue to receive oral pazopanib hydrochloride once daily in the absence of disease progression or unacceptable toxicity. NOTE: **After course 9, chemotherapy will be interrupted for 1 week. Blood samples are collected from some patients periodically for pharmacokinetic and biomarker studies. After completion of study treatment, patients are followed up at 3 weeks, every 3 months for 2 years, and then every 6 months for 3 years. ;
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