Brief Title
First-line Intraperitoneal Cisplatin and Etoposide Chemotherapy for Ovarian Cancer
Official Title
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)
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
12-month disease non-progression rate
Secondary Outcome
Progression-free survival
Condition
Bulky Stage IIIC and IV Epithelial Ovarian Cancer
Intervention
PEip (weekly) and TCiv
Study Arms / Comparison Groups
Regimen B, PEip and TCiv therapy
Description: Weekly IP cisplatin plus etoposide followed by IV paclitaxel plus carboplatin or docetaxel plus carboplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
215
Start Date
April 2009
Completion Date
July 2016
Primary Completion Date
September 2015
Eligibility 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.
Gender
Female
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Rongyu Zang, MD,PhD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01669226
Organization ID
V01-2009-03
Secondary IDs
SGOG OV1
Responsible Party
Sponsor
Study Sponsor
Shanghai Gynecologic Oncology Group
Collaborators
Fudan University
Study Sponsor
Rongyu Zang, MD,PhD, Principal Investigator, Shanghai Gynecologic Oncology Group
Verification Date
December 2016