Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer
- Conditions
- Ovarian Cancer
- Registration Number
- NCT00886717
- Lead Sponsor
- Asan Medical Center
- Brief Summary
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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 74
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose and recommended phase II dose (Phase I) Efficacy, in terms of CA-125 response rate after 6 courses of therapy (Phase II)
- Secondary Outcome Measures
Name Time Method Preliminary antitumor activity, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival (Phase I) Overall response (Phase II) Objective response rate as measured by RECIST criteria (Phase II) Overall survival (Phase II) Safety profiles (Phase I) Safety and toxicity (Phase II)
Trial Locations
- Locations (4)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center - University of Ulsan College of Medicine
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of