Ovarian GOG trials

GOG 115 Homesley et al Gyn Onc 1999

Phase II trial of BEP as first line for stromal tumors BEP is an active combination for first line in stromal tumors 37% were negative for residual disease at 2nd look xl 61% had grade 4 myelosuppression

GOG 116 Williams et al. Gyn Onc 2004

Phase II trial of carbo adn etoposide as adjuvant therapy for completely resected stage IB-III dysgerminoma active regimen as an alteratnive to BEP when goal is to minimize toxicity

GOG 252

Phase III 3 arm trial of the addition of bev to IV dose dense (DD) taxol v IP carbo D1/IV taxol DD v IV taxol 3 hr/IP cis D1/IP taxol D8 in optimal advanced ovarian cancer

GOG 182 Bookman JCO 2009

Phase III RCT 5 arm trial comparing the additoion of gem, doxil and topo to carbo/taxol v. carbo/taxol along in stage III/IV ovarian ca no improvment in PFS or OS

GOG 95 Young et al. JCO 2003

Phase III randomized trial of IP P32 v IV cyclophosphamide/cisplat (C/P) No difference is OS (but 17% lower in C/P), lower recurrence rate (28% v 35%) in C/P preferred therapy

GOG 262

Phase III tiral of every 3 week taxol in combo wiht carbo +/- bev in neoadjuvant, optimal or suboptimal advanced ovarian cancer

GOG 111 McGuire et al. NEJM 1996

Phase III trial comparing cyclophosphamide/cisplat v cisplat/paclitaxel in suboptimal (>1cm) debulked stage III/IV ovarian ca. Paclitaxel/cisplat superior with PFS (18 v. 13 mo) and OS (38 v. 24 mo)

GOG 218 Burger JCO abstract 2010

Phase III trial fo additoin of bev to carb/taxol (+ bev maintenance) in first line tx for advanced ovarian ca 3.8 mo improved PFS 14.1 v 10.3 mo in carbo/taxol/bev + maint arm OS data pending

GOG 104 Alberts et al. NEJM 1996

Phase III trial if IP cisplat/IV cyclophosphomide v. IV cisplat/cyclophosphomide in optimal (<2cm) debulked ovarian ca. improved OS in IP arm (49 v 41 mo) decreased tinnitus, hearing loss and myelosuppression in IP arm.

GOG 212

Phase III trial of 12 mo maintenance tx with taxol compared to no maintenance in advanced ovarian ca with complete response to primary tx

GOG 178 Markman JCO 2003

Phase III trial of 12 mo v 3 mo maintenance taxol in advanced stage ovarian ca afte rcomplete response to first line interim analysis showed improved PFS with 12 mo maintenance 28 v 21 months question of crossover in the study and no OS data because of early termination at interim analysis

GOG 132 Muggia et al. JCO 2000

Phase III trial of cis v paclitaxel v cis/paclitaxed in suboptimal (>1cm) stage III/IV ovarian ca cis monotherapy and combo were supreior to paclitaxel alone for RR, PFS but not OS toxicity profile was better in combo arm; monotherapy discontinued in 17% cis, 20% paclitaxel, 7% combo combo cis/paclitaxel remain preferred initial treatment option

GOG 134 Omura et al JCO 2003

Phase III trial of paclitaxel at 2 dose levels (135, 175, 250 mg/m2 over 24 hours) in platinum pre treated (presistant, recurrent, progressive) ovarian ca higher response rate with 250 dose; no difference with PFS, OS toxicity higher in 250 dose (despite addition of filgrastim) and 175 dose is recommended

GOG 213

Phase III trial of secondary cytoreduction adn the addition of bev to carbo/taxol + bev maintenance in stage II/IV ovarian cancer patients

GOG 114 Markman et al. JCO 2001

Phase III trial of standard cisp/paclitaxel v moderatly high dose carbo/paclitaxel/IP cis in opitmal (</= 1cm) stage III ovarian ca. PFS superior in carbo/paclitaxel/IP cis arm (28 v 22 mo); no statistical improvement in OS toxicity higher in experimental arm; 18% recieved </= 2 cycles IP therapy

GOG 172 Armstrong NEJM 2006

Phase III trial of taxol 24 hr/cis v taxol 24 hr/IP cis/IP taxol in optimal (<1cm) stage III ovarian ca improved PFS 23.8 v 18.3 and OS 65.6 v 49.7 w/ IP therapy only 42% in IP arm completed 6 cycles of assigned therapy

GOG 158 Ozols JCO 2003

Phase III trial os cis/taxol 24 hr v carbo (AUC 7.5)/taxol 3 hr in optimal <1cm ovarian ca carbo/taxol NOT inferior to cis/taxol adn has less toxicity and easier administration

GOG 152 Rose et al NEJM 2004

Randomized trial of secondary cytoreduction after 3 cycles of cis/paclitaxel followed by 32 more cycle s v no secondary cytoreduction in stage III ovarian cancer who had maximal attempt at primary surgery with >1cm residual remaining No benefit in PFS or OS from secondary

GOG 97 Hoskins et al. Am J Obstet Gyn 1994; McGuire et al. JCO 1995

Randomized trial of suboptimally (>1cm) debulked stage III/IV ovarian ca to determine if dose intensity (cyclophosphamide/cisplat increased dose for 4 q3wk cycles) v. standart tx (cyclophosphamide/cisplat 8 cycles) is superior. No improvement in RR, PFS< OS adn increased toxicity wiht dose intense chemo Secondary analysis showed significant improvement is OS with <2 cm residual disease

GOG 157 Bell et al Gyn Onc 2006

phase III trial of 3 v 6 cycles of adjuvant carbo/taxol in early stage ovarian ca nonsignificant 24% reduction in recurrence rate and no idfference in OS with additional toxicity of 6 cycles