A phase II study of cetuximab/paclitaxel/carboplatin for the initial treatment of advanced-stage ovarian, primary peritoneal, or fallopian tube cancer Journal Article

  

Authors:	Konner, J.; Schilder, R. J.; DeRosa, F. A.; Gerst, S. R.; Tew, W. P.; Sabbatini, P. J.; Hensley, M. L.; Spriggs, D. R.; Aghajanian, C. A.
Article Title:	A phase II study of cetuximab/paclitaxel/carboplatin for the initial treatment of advanced-stage ovarian, primary peritoneal, or fallopian tube cancer
Abstract:	Objective: Determine the safety and efficacy of cetuximab plus paclitaxel and carboplatin as initial treatment of stage III/IV ovarian cancer. Methods: An initial intravenous [IV] dose of cetuximab (400 mg/m2) was administered over 120 min followed by weekly IV infusions of cetuximab (250 mg/m2) administered over 60 min. Paclitaxel (175 mg/m2) and carboplatin (area under the curve [AUC] of 6) were administered IV every 21 days for 6 cycles. The order of administration was cetuximab followed by paclitaxel and then carboplatin. Patients achieving a clinical complete response after 6 cycles were eligible to continue weekly cetuximab for 6 months or until toxicity or disease progression. Safety was evaluated using NCI Common Toxicity Criteria version 2.0. Progression-free survival (PFS) at 18 months was determined and compared with historical controls. Results: Forty-one patients were enrolled in this study; 40 received treatment and were evaluable for toxicity, and 38 were evaluable for PFS. Grade 3/4 treatment-related toxicities included febrile neutropenia (12.5%), rash (2.5%), hypersensitivity reaction (7.5%), and hypomagnesemia (12.5%). Common grade 1/2 toxicities attributed to cetuximab included acneiform rash (82.5%), hirsutism (7.5%) or abnormal hair growth (25%), and nail disorders (22.5%), which in 3 cases resulted in the patient's discontinuation from the study. Median PFS was 14.4 months, and PFS at 18 months was 38.8%. Conclusions: The combination of cetuximab with paclitaxel and carboplatin is adequately tolerated as primary therapy for ovarian cancer but did not demonstrate prolongation of PFS when compared to historical data. © 2008 Elsevier Inc. All rights reserved.
Keywords:	adult; controlled study; aged; disease-free survival; middle aged; major clinical study; clinical trial; drug tolerability; fatigue; advanced cancer; area under the curve; ascites; cancer combination chemotherapy; diarrhea; dose response; drug efficacy; drug safety; drug withdrawal; hypophosphatemia; paclitaxel; chemotherapy, adjuvant; neoplasm staging; ovarian cancer; ovarian neoplasms; carboplatin; controlled clinical trial; infection; multiple cycle treatment; ovary cancer; peritoneum cancer; phase 2 clinical trial; peritoneal neoplasms; nausea; vomiting; antineoplastic combined chemotherapy protocols; dehydration; cetuximab; abdominal pain; backache; drug hypersensitivity; dyspnea; febrile neutropenia; hypomagnesemia; loading drug dose; nail disease; rash; hypokalemia; hyponatremia; hypotension; skin exfoliation; cancer regression; antibodies, monoclonal; disease severity; pancreatitis; acne; urinary tract infection; hair disease; fallopian tube neoplasms; lethargy; phase ii; drug dose sequence; hypocalcemia; angioneurotic edema; sinus tachycardia; hyperhidrosis; uterine tube tumor; early intervention; hirsutism; musculoskeletal pain; sinusitis; consciousness disorder
Journal Title:	Gynecologic Oncology
Volume:	110
Issue:	2
ISSN:	0090-8258
Publisher:	Elsevier Inc.
Date Published:	2008-08-01
Start Page:	140
End Page:	145
Language:	English
DOI:	10.1016/j.ygyno.2008.04.018
PUBMED:	18554700
PROVIDER:	scopus
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-47249145102&partnerID=40&md5=a5f3f0a0af8b49ab803eec818bef1c8a
Notes:	--- - "Cited By (since 1996): 21" - "Export Date: 17 November 2011" - "CODEN: GYNOA" - "Source: Scopus"

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