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

Publication Information Expand/Collapse

2016

OV21/PETROC: A randomized Gynecologic Cancer Intergroup (GCIG) phase II study of intraperitoneal (IP) versus intravenous (IV) chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer (EOC)

H Mackay;CJ Gallagher;W Parulekar;JA Ledermann;D Armstrong;C Gourley;I Romero;A Feeney;P Bessette;M Hall;JI Weberpals;G Hall;S Lau;P Gauthier;M Fung-Kee-Fung;E Eisenhauer;C Winch;D Tu;D Provencher Journal of Clinical Oncology 34, 2016 (suppl; abstr LBA5503);American Society of Clinical Oncology Annual Meeting (June 3-7, 2016, Chicago, IL), oral