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)
- 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.
- 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.