Paclitaxel-Loaded Polymeric Micelle and Carboplatin as First-Line Therapy in Treating Patients With Advanced Ovarian Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as paclitaxel-loaded polymeric micelle and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel-loaded polymeric micelle and carboplatin and to see how well they work as first-line therapy in treating patients with advanced ovarian cancer.

Detailed Description
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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.

Official Title
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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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: carboplatin
* Drug: paclitaxel-loaded polymeric micelle


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed advanced ovarian cancer Measurable disease by RECIST criteria No prior or concurrent CNS metastasis PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 6 months Clinically acceptable blood, kidney, and spleen function Not pregnant or nursing Fertile patients must use effective contraception No preexisting sensory or motor neuropathy ≥ grade 1 No other malignancies within the past 5 years PRIOR CONCURRENT THERAPY: No prior chemotherapy for ovarian cancer No prior immunotherapy or hormonal therapy for ovarian cancer No prior radiotherapy to the pelvis or abdominal cavity More than 2 weeks since prior major surgery other than debulking surgery

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: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: carboplatin|nan|
|Drug: paclitaxel-loaded polymeric micelle|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose and recommended phase II dose (Phase I) |  |  | 
| Efficacy, in terms of CA-125 response rate after 6 courses of therapy (Phase II) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary antitumor activity, in terms of objective response rate (complete response and partial response), time to tumor progression, and progression-free survival (Phase I) |  |  | 
| Safety profiles (Phase I) |  |  | 
| Objective response rate as measured by RECIST criteria (Phase II) |  |  | 
| Overall survival (Phase II) |  |  | 
| Overall response (Phase II) |  |  | 
| Safety and toxicity (Phase II) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIA ovarian epithelial cancer, stage IIIB ovarian epithelial cancer, stage IIIC ovarian epithelial cancer, stage IV ovarian epithelial cancer, stage IIIA ovarian germ cell tumor, stage IIIB ovarian germ cell tumor, stage IIIC ovarian germ cell tumor, stage IV ovarian germ cell tumor