Study to Evaluate the Efficacy and Safety of Genexol-PM Once a Week for Gynecologic Cancer

Study Overview
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Brief Summary
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Dose-dense paclitaxel (Genexol®-PM) once a week in combination with carboplatin every 3 weeks for gynecologic cancer (adult solid tumor): a phase I trial.

Official Title
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Dose-dense Paclitaxel (Genexol®-PM) Once a Week in Combination With Carboplatin Every 3 Weeks for Gynecologic Cancer (Adult Solid Tumor): a Phase I Trial

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Drug: Genexol-PM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who aged 20 years or older and under 80 year old female Patients who were diagnosed histologically or cytologically or who were scheduled to reccur as an gynecologic cancer (epithelial ovarian cancer , fallopian tube cancer, primary peritoneal cancer, cervical cancer, uterine corpus cance, etc) Patients seemed appropriate for Paclitaxel and Carboplatin combination therapy for the treatment Patients whose ECOG performance score are 0-2 Patients who have adequate blood, kidney and liver function on screening within 14 days before the administration of the test drugs Hb ≥ 10g/dl: Patients with less than 10g/dl of hemoglobin level were not allowed to use the test drugs unless they were recovered to 10g/dl or more. ANC ≥ 1500/mm3 Platelet Count ≥ 100,000/mm3 Serum AST and ALT ≤ 2.5 X ULN Serum ALP ≤ 2.5 X ULN Serum creatinine ≤ 2.5 X ULN Patients who participated voluntarily and who provided written informed consent before participating in the study Exclusion Criteria: Patients with the history of carcinoma in the past 5 years other than gynecologic cancer Patients who received radiotherapy at abdominal cavity or pelvis Patients who were receiving immunotherapy or hormone therapy Patients who received a major surgery other than debulking surgery within 2 weeks before the screening Patients with a past or present medical history of metastasis in central nervous system (CNS) Patients with NCI CTCAE V4.0 Grade 1 or more sensory or motor neuropathy Patients with severe comorbidities as follows medical or mental condition impossible to understand the clinical trial and provide a written informed consent, based on the investigators' decision severe cardiovascular disease (such as ischemic heart disease requiring medical therapy, myocardial infarction within the last 6 months, and grade 2 4 congestive heart failure defined by New York Heart Association criteria) uncontrolled active infectious disease hypersensitivity to the test drugs or the vehicle Patients who participated in another study within 4 weeks before the screening Pregnant, lactating women or Patients who do not use contraceptive methods that can be medically accepted to the possibility of pregnancy in female volunteers

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Genexol-PM 100mg/m2 IV infusion D1,D8,D15 Carboplatin 5 AUC IV infusion D1 | Drug: Genexol-PM<br>* Cremophor EL-free polymeric micelle of paclitaxel<br>|
| Experimental: Cohort 2<br>Genexol-PM 120mg/m2 IV infusion D1,D8,D15 Carboplatin 5 AUC IV infusion D1 | Drug: Genexol-PM<br>* Cremophor EL-free polymeric micelle of paclitaxel<br>|
| Experimental: Cohort 3<br>Genexol-PM 120mg/m2 IV infusion D1,D8,D15 Carboplatin 6 AUC IV infusion D1 | Drug: Genexol-PM<br>* Cremophor EL-free polymeric micelle of paclitaxel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum tolerated dose (MTD) | MTD was determined as the dose where more than 2 out of 6 subjects experienced DLT | 2 years | 
| The recommended dose for the phase II study | Determined as the recommended dose for a phase 2 study based on the adverse events and toxicities at each dose groups | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dose limiting toxicity (DLT) | Dose limiting toxicity (DLT) was defined as one of the following cases. NCI CTCAE V3.0 Grade 3 or more hypersensitivity despite premedication, Non-Hematological Toxicity other than nausea and vomiting, Hematological toxicity. | 2 years | 
| Toxicities | Clinical/laboratory toxicities were monitored after the treatment, in order to evaluate safety and tolerance of the test drugs, and adverse events, which were maintained until visit on discontinuation date, were followed until recovered or stabilized | 2 years |