SWOG clinical trial number
OV21
A Phase II/III Study of Intraperitoneal (IP) plus Intravenous (IV) Chemotherapy versus IV Carboplatin plus Paclitaxel in Patients with Epithelial Ovarian Cancer Optimally Debulked at Surgery following Neoadjuvant Intravenous Chemotherapy - NCIC-CTG
Closed
Phase
Abbreviated Title
IP plus IV chemo vs IV chemo in debulked ovarian
Activated
02/01/2012
Closed
02/28/2014
Participants
Research committees
Gynecologic Cancer
Treatment
Cisplatin
Paclitaxel
Carboplatin
Eligibility Criteria Expand/Collapse
Pts with histologically confirmed epithelial adv. ovarian, serous type peritoneal or fallopian tube ca with optimal delayed primary debulking surgery following 3-4 cycles of neoadjuvant platinum-based chemo. (no other prior tx allowed); Pts. w/ovarian ca of clear cell histology are eligible; FIGO Stage IIB-III at diagnosis (Stage IV eligible if the only criterion for stage IV is pleural effusion cytologically positive for ovarian ca; ECOG PS 0-2; age > or = 18; granulocytes > or = 1500; platelets > or = 100,000; creat and bilirubin < or = UNL; AST or ALT < or = 2.5XUNL; no uncontrolled atrial or ventricular arrhythmias unless managed with implanted pacemaker; no documented MI within last 5 months; no diagnosis of bowel obstruction