(a) Monoclonal Antibodies
Study and Year | CT no. | Phase | # Pts | Therapy | Selection criteria | Outcome | Comments |
---|---|---|---|---|---|---|---|
Secord et al. 2008 [97] | NCT 00086892 | II | 28 | Cetuximab + Carboplatin | Recurrent, platinum-sensitive disease | CR: 3 pts | Response rate criteria not met for next stage of accrual. 26 pts were EGFR positive by IHC. |
PR: 6 pts | |||||||
SD: 8 pts | |||||||
Konner et al. 2008 [98] | NCT 00063401 | II | 40 | Cetuximab + Paclitaxel + Carboplatin | Grade III-IV debulked tumor, EGFR positive by IHC | Median PFS: 14.4 months | Combination was adequately tolerated. No increase in PFS when compared to historical data. |
PFS at 18 months: 39% | |||||||
Schilder et al. 2009 [96] | II | 25 | Cetuximab | Persistent or recurrent ovarian or primary peritoneal disease, EGFR positive tumors by IHC | 12 serologic markers examined before and during treatment. No correlation between PFS and marker changes, but high baseline of markers associated with earlier disease progression. | ||
PR: 1 pt | |||||||
SD: 9 pts | |||||||
Seiden et al. 2007 [99] | NCT 00073541 | II | 37 | Matuzumab | Recurrent platinum-refractory disease, EGFR positivity by IHC | No objective response | Primary objective was pharmacodynamic; signal transduction evaluation. 75 pts were screened for EGFR status. |
SD: 16%–22% | |||||||
Bookman et al. 2003 [101] | GOG-160 | II | 41 | Trastuzumab | Persistent and/or refractory disease with 2-3+ HER2 by IHC | CR: 1 pt | Serum HER2 levels not associated with clinical outcome. |
PR: 2 pts |