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Regimen	Clin Status • Clin Indic • Enrollment	Protocol Desc • ID	Toxicity	Response	Institution • Reference
Regimen 1 Cetuximab + Carboplatin + Paclitaxel Details	Phase Ib/IIa (begin 12/00, closed 10/03) USA non-small cell lung cancer (NSCLC), chemotherapy-naive, advanced Enrolled: 31 Eval Resp: 31	Eligibility criteria included tumor evidence of EGFr expression >/=1+. Paclitaxel (225 mg/m²) and carboplatin (AUC=6) were administered on day 1, every 3 weeks. Cetuximab was administered at a loading dose of 400 mg/m² IV, over 2 hours, 1 week prior to the start of the chemotherapeutic regimen, and then weekly at 250 mg/m² IV, over 1 hour. Cetuximab was administered prior to chemotherapy. Patients were treated until tumor progression or because of intolerable toxicity. Patients who did not tolerate chemotherapy could continue on maintenance cetuximab alone. Patients were evaluated for tumor response at the end of every 2 cycles of therapy and evaluated for safety throughout the study. Protocol ID: CP02-9932	The most common toxicity was acne-like rash and the most common Grade 3 toxicity was fatigue.	CR: 9/31 (29%) PR: 20/31 (35.5%) OR: 64.5% MST: 472 days	• Kelly K, etal, ASCO03, Abs. 2592
Regimen 1 Cetuximab + Cisplatin Details	Phase I (closed 9/99) USA head and neck cancer, squamous cell carcinoma, recurrent and metastatic Enrolled: 6-12 patients (3-6 in each treatment arm)	Erbitux IV once weekly for 6 weeks, first loading dose administered over 60 or 120 minutes, subsequent maintenance doses administered over 60 minutes. Cisplatin infusion over 120 minutes once every 3 weeks for 6 weeks, 1 hour following Erbitux. Protocol ID: MSKCC-97079, NCI-G98-1377, IMCL-CP02-9608	Adverse events were fever, allergic reactions, and Grade 3 skin toxicity manifested as follicular rash or nail bed changes, which fully resolved after cessation of treatment.	CR: 2/9 CR PR: 4/9 PR SD: 1/9 SD OR: 66%	Memorial Sloan-Kettering Cancer Center • Mendelsohn J, etal, ASCO99, Abs 1502:389a; Rubin MS, etal, ASCO00, Abs. 1860
Regimen 1 Cetuximab + Cisplatin Details	Phase I (closed 6/01) USA head and neck cancer, squamous cell carcinoma, recurrent or refractory Enrolled: 38 (with stable disease patients following 6 weeks of platinum-based chemotherapy) Eval Resp: 38	Erbitux loading dose of 400 mg/m² followed by 250 mg/m² weekly. IV cisplatin was administered at the same dose and schedule previously administered, either 100 mg/m² if with paclitaxel or 75mg/m² if with 5-FU.	The most commonly reported adverse events related to cetuximab therapy were folliculitis/acne and allergic reactions.	CR: 1/38 (3%) CR PR: 7/38 (18%) PR SD: 22/38 (58%) SD OR: 21%	• Hong WK, etal, ASCO01, Abs.895:224a
Regimen 1 Cetuximab + Cisplatin Regimen 2 Placebo + Cisplatin Details	Phase III (begin 6/99, closed 8/01) USA head and neck cancer, squamous cell carcinoma Enrolled: 118 Eval Tox: 64 Eval Resp: 44	Arm I patients are administered IV Erbitux (400mg/m²) over 2 hours followed 1 hour later by IV cisplatin (100 mg/m²) over 2 hours on day 1 of course 1. Erbitux (250mg/m²) is administered over 1 hour on subsequent courses. Arm II patients are administered IV placebo over 2 hours followed 1 hour later by cisplatin as in arm I on day 1 of course 1. Placebo is administered over 1 hour on subsequent courses. Treatment is continued every 4 weeks for at least 6 courses in the absence of disease progression or unacceptable toxicity. Arm II patients who develop disease progression may then crossover to arm I treatment. Protocol ID: E-5397	Among 64 patients evaluable for toxicity, Grade 3/4 hypersensitivity was seen in 4 (6%), Grade 3/4 neutropenia in 11 (17%), and Grade 3/4 rash/desquamation in 7 (11%). There was 1 treatment-related death (0.8%). In updated results, the most common Grade 3/4 toxicities were electrolyte abnormalities, nausea, neutropenia. Grade 3 rash occurred in 17% of cisplatin plus Erbitux and 0% cisplatin + placebo treated-patients. There was 1 (0.8%) treatment-related death.	CR: 1/44 (2.3%) CR during the first 2 months of therapy. PR: 5.44 (11.4%) PR during the first 2 months of therapy. SD: 32/44 (72.7%) SD during the first 2 months of therapy. PD: 6/44 (13.6%) PD during the first 2 months of therapy. OR: ORR (Cisplatin + Cetuximab) = 25.7%; ORR (Cisplatin + Placebo) = 10.2% PFS: PFS (Cisplatin + Cetuximab) = 9.3 months; PFS (Cisplatin + Placebo) = 8.0 months OS: OS=7.2 months for the entire group; 2 year survival (Cisplatin + Cetuximab) = 14.2%; 2 year survival (Cisplatin + Placebo) = 7.4%	Eastern Cooperative Oncology Group • Burtness BA, ASCO02, Abs. 901:226a;
Regimen 1 Cetuximab + Cisplatin + Carboplatin Details	Phase II (completed 6/02) Europe head and neck cancer, squamous cell carcinoma, recurrent, metastatic Enrolled: 96 (11 F, 85 M) Eval Tox: 80 Eval Resp: 96	Erbitux (400 mg/m² loading dose followed by 250 mg/m² weekly) plus the same dose and schedule of platinum that the patients had previously progressed on.	Safety data is available for 80 patients. Drug-related adverse events attributable to Erbitux occurring in >10% patients and included rash (45%), acne (25%), dry skin (16%), asthenia (16%), fever (13%), and vomiting (10%), with all of these being grade 1/2 events, except grade 3 rash in 2.5%.	CR: 2/96 (2.1%) CR PR: 12/96 (12.5%) PR SD: 38/96 (39.6%) SD or MR lasting for at lease 6 weeks OR: 14.6% MST: MST for responders=269 days; Overall MST=178 days Median TTP: 66 days	• Baselga J, etal, ASCO02, Abs. 900

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