First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Gynecologic Oncology Group
• Collaborators: Fudan University; Shanghai Jiao Tong University School of Medicine; Shanghai Zhongshan Hospital
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Docetaxel; Etoposide; Etoposide phosphate; Paclitaxel; Taxane

Criteria

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.