|
Study and Year | CT no. | Phase | # Pts | Therapy | Selection criteria | Outcome | Comments |
|
Posadas et al. 2007 [203] | NCT 00049556 | II | 24 | Gefitinib | Platinum-refractory disease | No objective response | Protein correlates done with RPPA. No significant correlation between EGFR phosphorylation and tumor response |
SD: 37% for >2 months |
Schilder et al. 2005 [112] | NCT 00023699 | II | 27 | Gefitinib | Persistent or recurrent disease | PR: 1 pt | Analyses suggest trend towards responsiveness in EGFR positive (by IHC) pts. Activating mutations documented in the PR pt. |
Wagner et al. 2007 [115] | NCT 00189358 | II | 56 | Gefitinib + Tamoxifen | Disease refractory or resistant to platinum-taxane-based therapy | No objective response | EGFR positivity not a prerequisite; EGFR status not determined |
SD: 16 pts |
Gordon et al. 2005 [116] | | II | 34 | Erlotinib | Relapsed or progressive disease, EGFR positivity by IHC | PR: 2 pts | Primary goal was to estimate the objective tumor response rate to erlotinib as a single agent. |
| SD: 15 pts |
| |
Vasey et al. 2008 [118] | | Ib | 45 | Erlotinib + Docetaxel + Carboplatin | Chemonaïve pts | CR: 5 pts | Phase Ib dose finding study. Addition of erlotinib to other agents did not increase response rate. |
| PR: 7 pts |
| (23 evaluable) |
Nimeiri et al. 2008 [117] | NCT 00126542 | II | 13 | Erlotinib + Bevacizumab | Recurrent or refractory disease, ≤2 prior cytotoxic chemotherapies; no previous anti-EGFR or VEGFR therapies | | No indication of improvement over bevacizumab treatment only. No EGFR mutations detected; one EGFR 2+ IHC staining detected. |
CR: 1 pt |
PR: 1 pt |
|
Kimball et al. 2008 [122] | NCT 00317434 | I | 11 | Lapatinib + Carboplatin | Recurrent, platinum-sensitive disease | PR: 3 pts | No screening or measurement of EGFR or HER2 performed. |
SD: 3 pts |
Campos et al. 2005 [123] | | II | 105 | CI-1033 | Relapsed or refractory disease | No objective response | Baseline HER1-2 levels determined by IHC. No association between HER levels and SD. |
| SD: 26–34% |
|