Open-label, Multicenter, Phase I/II Trial to Evaluate Efficacy Safety of the Combination Therapy of Genexol-PM and Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer
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.
Interventional
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose and recommended phase II dose (Phase I)
Yes
Yong Man Kim, MD, PhD
Principal Investigator
Asan Medical Center
Unspecified
CDR0000639513
NCT00886717
May 2008
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