Table 2.
Current GCIG phase III and randomized phase II clinical trials for women with ovarian cancer (included recently closed trials, trials open to accrual, and trials in final design)
| Disease trajectory | Name of study | Lead and collaborating groups | Clinical question | Outcome |
|---|---|---|---|---|
| Disease trajectory | Name of study; trials registry # |
Lead & collaborating groups |
Clinical question | Current status; Outcome; N= sample size |
| Initial surgery | EORTC 55971 | EORTC, NCIC CTG | Primary surgery vs. neoadjuvant chemotherapy & interval cytoreduction |
Closed to accrual; no signicant difference in OS; N= 718 |
| CHORUS | MRC/NCRI | Primary surgery vs. neoadjuvant chemotherapy & interval cytoreduction |
Open to accrual 2006; N= 550 |
|
| AGO-OVAR OP.3 (LION) |
AGO-OVAR, AGO- Austria, KGOG, MITO |
Primary surgery +/− pelvic & para-aortic lymphadenectomy |
Open to accrual 2009; N=640 |
|
| Initial chemotherapy for women with epithelial ovarian cancer, tubal carcinoma, and primary peritoneal carcinoma |
AGO-OVAR-9 | AGO-OVAR, GINECO, NSGO |
Carboplatin/ paclitaxel +/− gemcitabine |
Significant improvement in PFS; no significant difference in OS (10); N=1567 |
| SCOTROC 4 | SGCTG, ANZGOG | Flat dosing of carboplatin vs intrapatient dose escalation |
No significant difference (11) |
|
| JGOG x | JGOG | Carboplatin + paclitaxel weekly vs every 3 weeks |
Significant improvement in PFS and OS (14) |
|
| JGOG 3019 | JGOG | Carboplatin (AUC 6) IV vs IP, both with IV weekly paclitaxel |
Open to accrual 2010; N= 754 |
|
| ICON-7 | MRC/NCRI, AGO-OVAR, ANZGOG, EORTC, GINECO, GEICO, NCIC CTG, NSGO |
Carboplatin/ paclitaxel +/− bevacizumab (7.5 mg/kg) |
Closed to accrual; data maturing; N=1528 |
|
| GOG 218 | GOG, GOG-Japan, ECOG, KGOG, NCCTG, NSABP, SWOG |
Carboplatin/ paclitaxel +/− bevacizumab (15 mg/kg) |
Closed to accrual; significant improval in PFS; N=1800 |
|
| MITO-7 | MITO, AGO-OVAR, MaNGO |
Weekly vs every 3 week carboplatin/ paclitaxel |
Open to accrual 2009; N=400 |
|
| GOG 252 | GOG | Carboplatin/ weekly paclitaxel/ bevacizumab vs. IP carboplatin/ weekly paclitaxel/ bevacizumab vs. IP cisplatin/ IV & IP paclitaxel / bevacizumab |
Open to accrual; N=1250 |
|
| NCIC CTG OV 21 | NCIC CTG, ANZGOG, GEICO, NCRI, SWOG |
Neoadjuvant chemotherapy-> interval cytoreduction -> carboplatin / paclitaxel weeks 1 & 2 vs. IP carboplatin every / paclitaxel weeks 1 & 2 vs cisplatin IP/ paclitaxel IV week 1 & IP week 2/ bevacizumab |
Open to accrual 2009; N=830 |
|
| AGO-OVAR-12 | AGO-OVAR, AGO- Austria, BGOG, GINECO, MANGO, MITO, NSGO, and select US sites |
Carboplatin/ paclitaxel +/− BIBF 1120 (Vargatef) |
Open to accrual 2009; N= 1300 |
|
| ICON 8 | NCRI | Carboplatin/paclitaxel both every 3 weeks vs. carboplatin every 3 weeks + weekly paclitaxel vs carboplatin/ paclitaxel both weekly |
In review; N= 1485 | |
| Initial chemotherapy for clear cell ovarian cancer |
JGOG 3017 | JGOG, GINECO, KGOG, MITO, SGCTG |
Carboplatin/paclitaxel vs. cisplatin/irinotecan in clear cell cancer |
Open to accrual 2007; N=652 |
| Initial chemotherapy for mucinous ovarian cancer |
mEOC/GOG 241 | NRCI/ SGCTG & GOG, AGO-OVAR, GINECO, KGOG, MANGO, NSGO |
Carboplatin/paclitaxel +/− bevacizumab vs oxaplatin/ capecitabine +/− bevacizumab in mucinous cancer |
Open to accrual 2010; N=332 |
| Initial chemotherapy for primary or recurrent sex-cord stromal tumors of the ovary |
GOG 264 (randomized phase II) |
GOG | Carboplatin/ paclitaxel vs. bleomycin/ etoposide/ platinum for chemotherapy- naïve primary or recurrent sex-cord stromal tumors of the ovary |
Open to accrual; N dependent on events in control arm |
| Consolidation | EORTC 55041 | EORTC, AGO-Ausria, ANZGOG, GINECO, MANGO, MRC/NCRI, |
Primary chemotherapy +/− erlotinib × 2 years |
Accrual complete; data maturing; N=835 |
| GOG 218 | GOG, GOG-Japan, ECOG, KGOG, NCCTG, NSABP, SWOG |
Primary chemotherapy +/− bevacizumab, both during chemotherapy and in consolidation |
Accrual complete; significant improvement in PFS; N=1800 |
|
| AGO-OVAR-16 | AGO-OVAR, AGO- Austria, ANZGOG, BGOG, GEICO, GINECO, ICORG, JGOG, KGOG, MANGO, MITO, NSGO, SWOG, and select US sites |
Primary chemotherapy +/− pazopanib × 1 year |
Open to accrual 2009; N= 900 |
|
| GOG 225 | GOG | Improved diet & exercise vs normal lifestyle in women disease-free after primary treatment |
Funding pending; N= 1400 |
|
| Platinum-sensitive recurrence |
AGO-OVAR-OP.2 DESKTOP II |
AGO-OVAR, AGO- Austria, MITO |
Evaluation of predictive factors for complete surgical resection |
Validation of AGO- DESKTOP I Score (12); N= 412 |
| CALYPSO | GINECO, AGO-Austria, AGO- OVAR, ANZGOG, EORTC, MANGO, MITO, NCIC CTG, NSGO |
Carboplatin/ paclitaxel +/− pegylated liposomal doxorubicin |
Significant different in favor of doxorubicin arm (13); N=976 |
|
| GOG 213 | GOG | Carboplatin/ paclitaxel +/− bevacizumab, +/− cytoreductive surgery |
Open to accrual; N= 660 for bevacizumab question; N= 360 for surgical questions |
|
| ICON 6 | MRC/NCRI, NCIC CTG, ANZGOG |
Carboplatin/paclitaxel +/− cediranib both with chemotherapy and in maintenance |
Open to accrual 2007; stage I, N=50; stage 2, N=600; stage 3, N=2000 |
|
| AGO-OVAR-OP.4 DESKTOP III |
AGO-OVAR | Cytoreductive surgery vs no surgery |
Open to accrual 2009; N= 385 (12) |
|
| HECTOR | NOGGO/ AGO-OVAR, AGO- Austria, GEICO |
Carboplatin/ topotecan vs carboplatin/ paclitaxel or carboplatin/ gemcitabine |
Closed to accrual; N=550 |
|
| MITO-8 | MITO, AGO-OVAR, BGOG, MANGO |
Liposomal doxorubicin vs carboplatin/ paclitaxel, with cross- over at progression |
Open to accrual 2009; N=253 |
|
| DDPC-PREOC (randomized phase II) |
SGCTG | Liposomal doxorubicin vs weekly carboplatin/ paclitaxel |
In review; N= 130 | |
| OVATYON | MANGO | Lipsomal doxorubicin + carboplatin vs liposomal doxorubicin + trabectidin |
Open to accrual; N=588 | |
| Platinum-resistant/ refractory ovarian cancer |
MITO-11 (randomized phase II) |
MITO | Weekly paclitaxel +/− pazopanib |
Open to accrual 2009; N=72 |
| AURELIA | GINECO, AGO-OVAR, GEICO, MITO, NSGO |
Chemotherapy +/− bevacizumab |
Open to accrual 2009; N=332 |