First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer

Phase 2

Completed

• Conditions: Bulky Stage IIIC and IV Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
• Interventions: Drug: PEip (weekly) and TCiv; Drug: TCiv

• Registration Number: NCT01669226
• Lead Sponsor: Shanghai Gynecologic Oncology Group

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2012-08-08
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-20
• Primary Completion: 2015-09
• Study Completion: 2016-07
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 215

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimen B, PEip and TCiv therapy	PEip (weekly) and TCiv	Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin
Regimen A: Standard TCiv therapy	TCiv	IV paclitaxel plus carboplatin or docetaxel plus carboplatin

Primary Outcome Measures

Name	Time	Method
12-month disease non-progression rate	12 months

Secondary Outcome Measures

Name	Time	Method
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
Progression-free survival	up to 120 months
adverse effects	Participants will be followed for the duration of hospital stay, an expected average of 5 weeks

Trial Locations

Locations (7)

Fudan University Cancer Hospital; 🇨🇳 Shanghai, China

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Ren Ji Hospital Affiliated to Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Suzhou Municipal Hospital; 🇨🇳 Suzhou, Jiangsu, China

Wuxi Cancer Hospital; 🇨🇳 Wuxi, Jiangsu, China

Zhongda Hospital Southeast University; 🇨🇳 Nanjing, Jiangsu, China

Shanghai Frist Maternity and Infant Hospital Affiliated to Tongji University; 🇨🇳 Shanghai, Shanghai, China