Last updated on August 2013

Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer


Brief description of study

RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.

Detailed Study Description

OBJECTIVES: Primary - Determine the maximum tolerated dose and recommended phase II dose of paclitaxel-loaded polymeric micelle and carboplatin as first-line therapy in patients with advanced ovarian cancer. (Phase I) - Evaluate the efficacy of this regimen, in terms of CA-125 response rate after 6 courses of therapy. (Phase II) Secondary - Assess, preliminarily, the antitumor activity of this regimen, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival, in these patients. (Phase I) - Evaluate the safety profiles of this regimen in these patients. (Phase I) - Determine the objective response rate, as measured by RECIST criteria, in patients treated with this regimen. (Phase II) - Determine the overall survival of patients treated with this regimen. (Phase II) - Determine the overall response in patients treated with this regimen. (Phase II) - Evaluate the safety and toxicity of this regimen in these patients. (Phase II) OUTLINE: This is a multicenter study. Patients receive paclitaxel-loaded polymeric micelle and carboplatin.

Clinical Study Identifier: NCT00886717

Contact Investigators or Research Sites near you

Start Over

Seoul National University Hospital

Seoul, Korea, Republic of
8.47miles
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.