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

Angeles Alvarez Secord, John A. Blessing, Deborah Kay Armstrong, William H. Rodgers, Zoe Miner, Mack N. Barnes, George Lewandowski, Robert S. Mannel

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)493-499
Number of pages7
JournalGynecologic Oncology
Volume108
DOIs
StatePublished - Mar 2008

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Carboplatin
Platinum
Epidermal Growth Factor Receptor
Ovarian Neoplasms
Hypersensitivity
Carcinoma
Neoplasms
Cetuximab
Exanthema
Area Under Curve
Therapeutics

Keywords

  • Cetuximab
  • Epidermal growth factor receptor
  • Ovarian cancer

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

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. / Secord, Angeles Alvarez; Blessing, John A.; Armstrong, Deborah Kay; Rodgers, William H.; Miner, Zoe; Barnes, Mack N.; Lewandowski, George; Mannel, Robert S.

In: Gynecologic Oncology, Vol. 108, 03.2008, p. 493-499.

Research output: Contribution to journalArticle

Secord, Angeles Alvarez ; Blessing, John A. ; Armstrong, Deborah Kay ; Rodgers, William H. ; Miner, Zoe ; Barnes, Mack N. ; Lewandowski, George ; Mannel, Robert S. / 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. In: Gynecologic Oncology. 2008 ; Vol. 108. pp. 493-499.
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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.",
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AU - Blessing, John A.

AU - Armstrong, Deborah Kay

AU - Rodgers, William H.

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AU - Barnes, Mack N.

AU - Lewandowski, George

AU - Mannel, Robert S.

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