PURPOSE: This phase II trial assessed the activity and tolerability of cetuximab (C225, Erbitux) in combination with carboplatin in patients with relapsed platinum-sensitive ovarian or primary peritoneal carcinoma. PATIENTS AND METHODS: Patients were to receive combination therapy with cetuximab (initial dose of 400 mg/m2 intravenously on cycle 1, day 1, followed by weekly infusions of 250 mg/m2) and carboplatin (AUC of 6 on day 1 and every 3 weeks). The primary objectives of this trial were to estimate the anti-tumor activity and adverse events of this combination therapy. Immunohistochemical expression of EGFR was evaluated in tumor specimens from patients enrolled in this trial. RESULTS: Of the 29 patients, 28 (97%) were eligible and evaluable for analysis of the efficacy and toxicity of cetuximab administered in combination with carboplatin. Of the evaluable entries, 26 had EGFR-positive tumors and the response rate in this group of patients was as follows: 9 demonstrated an objective response (3 CR; 6 PR) and 8 had stable disease. The response rate did not meet criteria for opening a second stage of accrual. The median time to progression was 9.4+ months (range: .9-22.2+). The most commonly observed adverse events were dermatologic toxicity (grade 3 in 32%), thrombocytopenia (grade 3 in 14%), and hypersensitivity reactions (grade 3 and 4 in 18%). CONCLUSIONS:Cetuximab administered in combination with carboplatin had modest activity in screened patients with EGFR-positive, relapsed platinum-sensitive ovarian or primary peritoneal carcinoma. Cetuximab was associated with an acneiform rash in a majority of patients and occasional serious hypersensitivity reactions.
RCT Entities:
PURPOSE: This phase II trial assessed the activity and tolerability of cetuximab (C225, Erbitux) in combination with carboplatin in patients with relapsed platinum-sensitive ovarian or primary peritoneal carcinoma. PATIENTS AND METHODS: Patients were to receive combination therapy with cetuximab (initial dose of 400 mg/m2 intravenously on cycle 1, day 1, followed by weekly infusions of 250 mg/m2) and carboplatin (AUC of 6 on day 1 and every 3 weeks). The primary objectives of this trial were to estimate the anti-tumor activity and adverse events of this combination therapy. Immunohistochemical expression of EGFR was evaluated in tumor specimens from patients enrolled in this trial. RESULTS: Of the 29 patients, 28 (97%) were eligible and evaluable for analysis of the efficacy and toxicity of cetuximab administered in combination with carboplatin. Of the evaluable entries, 26 had EGFR-positive tumors and the response rate in this group of patients was as follows: 9 demonstrated an objective response (3 CR; 6 PR) and 8 had stable disease. The response rate did not meet criteria for opening a second stage of accrual. The median time to progression was 9.4+ months (range: .9-22.2+). The most commonly observed adverse events were dermatologic toxicity (grade 3 in 32%), thrombocytopenia (grade 3 in 14%), and hypersensitivity reactions (grade 3 and 4 in 18%). CONCLUSIONS:Cetuximab administered in combination with carboplatin had modest activity in screened patients with EGFR-positive, relapsed platinum-sensitive ovarian or primary peritoneal carcinoma. Cetuximab was associated with an acneiform rash in a majority of patients and occasional serious hypersensitivity reactions.
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
Authors: José Baselga; José M Trigo; Jean Bourhis; Jacques Tortochaux; Hernán Cortés-Funes; Ricardo Hitt; Pere Gascón; Nadia Amellal; Andreas Harstrick; André Eckardt Journal: J Clin Oncol Date: 2005-07-11 Impact factor: 44.544
Authors: Roy S Herbst; Matthew Arquette; Dong M Shin; Karel Dicke; Everett E Vokes; Nozar Azarnia; Waun Ki Hong; Merrill S Kies Journal: J Clin Oncol Date: 2005-07-11 Impact factor: 44.544
Authors: Anthony T C Chan; Mow-Ming Hsu; Boon C Goh; Edwin P Hui; Tsang-Wu Liu; Michael J Millward; Ruey-Long Hong; Jacqueline Whang-Peng; Brigette B Y Ma; Ka F To; Matthias Mueser; Nadia Amellal; Xiao Lin; Alex Y Chang Journal: J Clin Oncol Date: 2005-04-04 Impact factor: 44.544
Authors: Christiane D Thienelt; Paul A Bunn; Nasser Hanna; Arthur Rosenberg; Michael N Needle; Michael E Long; Daniel L Gustafson; Karen Kelly Journal: J Clin Oncol Date: 2005-10-24 Impact factor: 44.544
Authors: Russell J Schilder; Michael W Sill; Xiaowei Chen; Kathleen M Darcy; Steven L Decesare; George Lewandowski; Roger B Lee; Cletus A Arciero; Hong Wu; Andrew K Godwin Journal: Clin Cancer Res Date: 2005-08-01 Impact factor: 12.531
Authors: Doris R Siwak; Mark Carey; Bryan T Hennessy; Catherine T Nguyen; Mollianne J McGahren Murray; Laura Nolden; Gordon B Mills Journal: J Oncol Date: 2009-11-19 Impact factor: 4.375