First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer (AICE)

Shanghai Gynecologic Oncology Group

Status and phase

Completed

Phase 2

Conditions

Bulky Stage IIIC and IV Epithelial Ovarian Cancer

Primary Peritoneal Carcinoma

Fallopian Tube Cancer

Treatments

Drug: TCiv

Drug: PEip (weekly) and TCiv

Study type

Interventional

Funder types

Other

Identifiers

NCT01669226

SGOG OV1 (Other Identifier)

V01-2009-03

Details and patient eligibility

About

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.

Full 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.

Enrollment

215 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.