A Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer

Study Overview
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Brief Summary
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The purpose of this study is to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin® Compared to Genexol® Plus Carboplatin® as a Firstline Treatment in Subjects With Ovarian Cancer.

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC
* Drug: Genexol® 175mg/m2 plus Carboplatin 5 AUC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who aged 18 years or older Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial Subjects who have histologically or cytologically confirmed unresectable or metastatic epithelial cancer of the exocrine pancreas. High-quality contrast-enhanced CT scanning is required to evaluate resectability. Measurable disease is not required. Exclusion Criteria: Subjects who have received prior radiation therapy (XRT) for pancreatic cancer unless progression was documented after XRT and 6 weeks have elapsed between completion of XRT and start of trial medication. Subjects who have had systemic treatment such as chemotherapy or immunotherapy, for pancreatic cancer. However, prior use of chemotherapy, e.g. 5-FU or capecitabine, for radiation sensitization is allowed. If gemcitabine was given in the adjuvant setting, only subjects relapsed with cancer after 6 months of completing the last dose of gemcitabine can participate in the trial. Subjects who have had a major surgery within 2 weeks prior to the screening/baseline visit

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genexol®-PM plus Carboplatin<br> | Drug: Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC<br> <br> |
| Active Comparator: Genexol® plus Carboplatin<br> | Drug: Genexol® 175mg/m2 plus Carboplatin 5 AUC<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of Genexol®-PM plus Carboplatin versus Genexol® plus Carboplatin in subjects with ovarian cancer based on Composite Response Rate | Proportion of subjects with CA125 and RECIST composite response rate was evaluated and compared between the groups. CA125 was evaluated among subjects without a measurable disease, while RECIST was evaluated among subjects with a measurable disease; discordance between the response rates by RECIST and CA125 were deemed as nonresponse. | up to 6 cycles | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | The period from the date of first administration to the date of the patient's death | up to 3 years | 
| Progression Free Survival | The period from the date of first administration to the date of objective tumor progression by CA125 and RECIST or death | up to 3 years | 
| Time to Progression | The period from the date of first administration to the date of tumor progression by CA125 and RECIST or objective tumor progression, excluding progression-free death | up to 3 years |