First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the role of an additional intraperitoneal chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.

Detailed Description
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This exploratory trial is to compare the efficacy of sequential chemotherapy, intraperitoneal chemotherapy followed by intravenous chemotherapy, versus intravenous chemotherapy alone in the first-line therapy for ovarian cancer.

Official Title
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A Phase II,Randomized Study of an Addition Intraperitoneal Cisplatin and Etoposide to Standard First-line Therapy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)

Conditions
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Bulky Stage IIIC and IV Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Intervention / Treatment
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* Drug: PEip (weekly) and TCiv
* Drug: TCiv


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years to ≤ 75 years. Epithelial ovarian cancer with pathology confirmed stage IIIc or IV, expect for lymph node metastasis alone Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 1cm Available to receive intraperitoneal chemotherapy 5-10 days postoperative, or no more than postoperative 14 days for those with bowel resection. ECOG performance 0-2. No more than 3 cycles of chemotherapy prior to surgery. Laboratory testing within 7 days of registration: hematopoietic: absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3. Hepatic: bilirubin less than 1.25 times upper limit of normal (ULN); Bilirubin < 2.0, SGPT less than 2 times ULN. Renal: creatinine less than 1.6 mg/dL, OR creatinine clearance greater than 40 mL/min. Comply with intraperitoneal chemotherapy and follow-up. Written informed consent. Exclusion Criteria: Low-malignant potential ovarian tumor. Laboratory testing insufficiency. Hemoglobin < 10 g/dL. Renal insufficiency with serum creatinine > 1.6. Bone marrow dysfunction: absolute neutrophil count less than 1,500/mm3; Platelet count less than 80,000/mm3. Active infection. Clinically significant gastrointestinal abnormalities. Active coronary artery disease, cerebrovascular disease, restrictive or obstructive pulmonary disease, or congestive heart failure. Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up. Prior invasive malignancies within the last 5 years showing activity of disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Regimen B, PEip and TCiv therapy<br>Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin | Drug: PEip (weekly) and TCiv<br>* IP: cisplatin 50mg/m2 and etoposide 100mg/m2, weekly, 4 times; 14 days later IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5<br>* Other names: taxane;|
| Active Comparator: Regimen A: Standard TCiv therapy<br>IV paclitaxel plus carboplatin or docetaxel plus carboplatin | Drug: TCiv<br>* IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5<br>* Other names: platinum;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month disease non-progression rate |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | up to 120 months | 
| Completion rate of intraperitoneal chemotherapy. |  | up to 6 months | 
| Quality of life assessments |  | baseline; 4th week of intraperitoneal,chemotherapy, 6th cycle of intravenous chemotherpy, 3, 6, and 12 months after first-line chemotherapy. | 
| Overall Survival |  | up to 120 months | 
| adverse effects |  | Participants will be followed for the duration of hospital stay, an expected average of 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cancer, intraperitoneal chemotherapy