drugset / Trial / NCT01468909

Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Persistent or Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer

NCT01468909 ↗

RandomizedParallel-groupDouble-blindTreatment

Summary

This randomized phase II trial studies how well paclitaxel when given together with or without pazopanib hydrochloride works in treating patients with ovarian epithelial, fallopian tube, or peritoneal cavity cancer that is persistent or has come back. Drugs used in chemotherapy, such as paclitaxel work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pazopanib hydrochloride may stop the growth of tumor cells by blocking blood flow to the tumor or by blocking some of the enzymes needed for cell growth. It is not yet known whether paclitaxel is more effective when given with or without pazopanib hydrochloride in treating ovarian epithelial, fallopian tube, and peritoneal cavity cancer.

Timeline

Start
2011-12-12
Primary completion
2018-01-27
Completion
2018-01-27

Outcome

Missed primary endpoint

paper Median PFS was 7.5 vs 6.2 months for pazopanib plus paclitaxel vs paclitaxel alone, respectively (HR, 0.84; 90% CI, 0.57-1.22; P = .20). PMID 29242937 ↗

paper The combination of pazopanib plus paclitaxel is not superior to paclitaxel in women with recurrent ovarian cancer. PMID 29242937 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pazopanib Small molecule 800 mg Oral
Background Paclitaxel Small molecule 80 mg/m2 Intravenous