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

Study Overview
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Brief Summary
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The purpose of this study is to determine the maximum tolerated dose of Genexol®-PM plus Carboplatin and evaluate the efficacy and safety of Genexol®-PM plus Carboplatin regimen in subjects with advanced ovarian cancer.

Detailed Description
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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.

Official Title
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Open-label, Multicenter, Phase I Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC
* Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC
* Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Level One<br> | Drug: Genexol-PM 220mg/㎡, Carboplatin 5AUC<br>* Genexol-PM 220mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.<br>|
| Experimental: Dose Level Two<br> | Drug: Genexol-PM 260mg/㎡, Carboplatin 5AUC<br>* Genexol-PM 260mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.<br>|
| Experimental: Dose Level Three<br> | Drug: Genexol-PM 300mg/㎡, Carboplatin 5AUC<br>* Genexol-PM 300mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer. |  | until either MTD is achieved or maximum planned dose is tested | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (Complete Response (CR) + Partial Response (PR)) |  | about 1 year (until end of trial) | 
| Time to Tumor Progression |  | about 1 year (until end of trial) | 
| Overall Survival |  | about 1 year (until end of trial) | 
| Safety profiles |  | about 1 year (till end of trial) |