Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer

This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of the combination therapy with Genexol®-PM and Carboplatin and to evaluate the efficacy and safety of Genexol®-PM when administered with Carboplatin in subjects with advanced ovarian cancer after debulking surgery.

Inclusion criteria

• Women ≥ 18 years old.
• Signed informed consent before inclusion.
• Subjects who have histologically or cytologically confirmed advanced epithelial ovarian cancer.(FIGO IIIB-IV)
• Subjects who have measurable disease by RECIST after debulking surgery.
• ECOG performance status of 0, 1, or 2.
• Estimated life expectancy of more than 6 months
• Subjects who have the clinically acceptable function of blood, kidney and liver at screening visit

• Hb ≥ 10g/dl
• ANC ≥ 1.5×10^9/L
• Platelet Count ≥ 100×10^9/L
• Serum total bilirubin ≤ 1.5×ULN
• Serum AST and ALT ≤ 2.5×ULN
• Serum ALP ≤ 2.5×ULN
• Serum creatinine ≤ 1.5×ULN

Exclusion criteria

• Subjects who have received chemotherapy for ovarian cancer other than debulking surgery.
• Subjects who have a history of radiotherapy to pelvis or abdominal cavity
• Subjects who receive immunotherapy or hormonal therapy for ovarian cancer
• Subjects who have other malignancies within the past 5 years
• Subjects who have had a major surgery other than debulking surgery within 2 weeks prior to the screening/baseline visit
• Subjects who have a history of metastasis or currently have a metastasis to the central nervous system(CNS)
• Subjects who have a preexisting sensory or motor neuropathy of grade ≥ 1 based on NCI CTCAE V3.0
• Subjects who have serious medical condition

• Uncontrolled or severe cardiovascular disease(Ischemic heart disease, myocardial infarction within the last 6 months, congestive heart failure)
• Uncontrollable infection
• Previous allergic reactions in connection with paclitaxel and carboplatin
• Subjects who participate another clinical trial within the last 4 weeks before inclusion