Efficacy Study of Neoadjuvant Chemotherapy to Treat Advanced Ovarian Cancer

Study Overview
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Brief Summary
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Neoadjuvant chemotherapy is alternative treatment option to upfront cytoreductive surgery to treat advanced ovarian cancer. Paclitaxel plus carboplatin is most frequently selected chemotherapeutic regimen for neoadjuvant chemotherapy. Docetaxel had similar therapeutic efficacy compared to paclitaxel in adjuvant chemotherapy trials in ovarian cancer. However, docetaxel had more favorable toxicity profile. Therefore, the investigators aimed to evaluate the efficacy of docetaxel plus carboplatin as neoadjuvant chemotherapy in patients with advanced ovarian cancer.

Official Title
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Phase II Trial of Docetaxel and Carboplatin as Neoadjuvant Chemotherapy in Patients With Advanced Ovarian Cancer

Conditions
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Advanced Ovarian Cancer

Intervention / Treatment
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* Drug: Neoadjuvant chemotherapy
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced epithelial, tubal, or primary peritoneal cancer Cancer cells in paracentesis, thoracentesis, or laparoscopic surgery Less probability of complete cytoreduction Age: 20-80 years GOG performance status: 0-3 Adequate organ function Bone marrow: ANC ≥ 1,500mm3, Platelet ≥ 100,000/mm3, Hb ≥ 10.0 g/dl Kidney: Creatinine ≤ 1.25 × UNL Liver: AST, ALT ≤ × 2.5 UNL (in case of liver metastasis, AST, ALT ≤ × 5 UNL), alkaline phosphatase ≤ 5 x UNL, bilirubin ≤ 1.5 mg/ mm3 Exclusion Criteria: Previous chemotherapy or pelvic radiation therapy Final diagnosis is other malignancies Coincidental Other malignancies within 5 years except carcinoma in situ of uterine cervix History of severe allergy Pregnancy, lactating woman Uncontrolled medial disease Bowel obstruction requiring immediate surgery Etc.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy<br>Neoadjuvant chemotherapy with docetaxel plus carboplatin | Drug: Neoadjuvant chemotherapy<br>* Docetaxel 75mg/m2BAS, q 3 weeks, 3 cycles<br>Drug: Carboplatin<br>* Carboplatin AUC 5, q 3 weeks, 3 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 1 month after completion of study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | Before each chemotherapy, an average of 3 week | 
| Disease-free survival |  | 2 years after completion of study treatment | 
| Overall survival |  | 2 years after completion of study treatment | 
| The number of participants who achieved optimal cytoreduction |  | 1 month after completion of study treatment |