Title | Phase II trial of cetuximab and carboplatin in relapsed platinum-sensitive ovarian cancer and evaluation of epidermal growth factor receptor expression: a Gynecologic Oncology Group study. |
Publication Type | Journal Article |
Year of Publication | 2008 |
Authors | Secord AAlvarez, Blessing JA, Armstrong DK, Rodgers WH, Miner Z, Barnes MN, Lewandowski G, Mannel RS |
Corporate Authors | Gynecologic Oncology Group |
Journal | Gynecol Oncol |
Volume | 108 |
Issue | 3 |
Pagination | 493-9 |
Date Published | 2008 Mar |
ISSN | 1095-6859 |
Keywords | Adult, Aged, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Carboplatin, Cetuximab, Drug Administration Schedule, Drug Resistance, Neoplasm, ErbB Receptors, Female, Gene Expression Regulation, Neoplastic, Humans, Infusions, Intravenous, Middle Aged, Neoplasm Recurrence, Local, Neoplasms, Hormone-Dependent, Ovarian Neoplasms, Treatment Outcome |
Abstract | 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. |
DOI | 10.1016/j.ygyno.2007.11.029 |
Alternate Journal | Gynecol Oncol |
PubMed ID | 18191993 |
PubMed Central ID | PMC2744339 |
Grant List | U10 CA027469-24 / CA / NCI NIH HHS / United States CA 27469 / CA / NCI NIH HHS / United States U10 CA027469 / CA / NCI NIH HHS / United States U10 CA037517-24 / CA / NCI NIH HHS / United States U10 CA037517 / CA / NCI NIH HHS / United States CA 37517 / CA / NCI NIH HHS / United States |
Related Faculty:
William Rodgers, M.D., Ph.D.