Phase II trial of irinotecan plus cisplatin in patients with recurrent or metastatic squamous carcinoma of the head and neck

Jill Gilbert, Anthony Cmelak, Yu Shyr, James Netterville, Brian B. Burkey, Robert J. Sinard, Wendall G. Yarbrough, Christine H. Chung, Joseph M. Aulino, Barbara A. Murphy

Research output: Contribution to journalArticle

Abstract

BACKGROUND. Patients with recurrent or metastatic HNC have a poor response and survival with currently available chemotherapy agents. Thus, new agents are needed. The authors report the results of a phase II trial of irinotecan and cisplatin in patients with metastatic or recurrent HNC. METHODS. Patients were treated with irinotecan 65 mg/m2 IV over 90 minutes and cisplatin 30 mg/m2 were administered intravenously weekly for four weeks, followed by a two week rest. However, after 17 patients were treated with weekly irinotecan at a dose of 65 mg/m2, toxicity analysis demonstrated the poor tolerance of that dose in this patient population. Thus, the protocol was amended, and irinotecan was dose reduced to a starting dose of 50 mg/m 2. Twenty-three additional patients were treated with this dose. RESULTS. Forty patients were enrolled on study between February 2002 and April 2006, 17 patients at the first dose level and 23 patients at the amended dose level. Overall, 12 of 17 patients (71%) treated with irinotecan 65 mg/m 2 experienced clinically significant grade 3 or 4 toxicity. Twelve patients required dose reductions. Toxicity was reduced but 17% of patients still experienced grade 3 or 4 toxicity on the lower irinotecan dose. The response rate was 35% for patients treated at irinotecan 65 mg/m2 and 22% for patients treated at 50 mg/m2. No complete responses were noted. CONCLUSIONS. The combination of irinotecan and cisplatin is efficacious in a poor prognosis group of patients but toxicity is substantial.

Original languageEnglish (US)
Pages (from-to)186-192
Number of pages7
JournalCancer
Volume113
Issue number1
DOIs
StatePublished - Jul 1 2008
Externally publishedYes

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irinotecan
Cisplatin
Squamous Cell Carcinoma
Neck
Head

Keywords

  • Cisplatin
  • Concurrent chemoradiotherapy
  • Irinotecan
  • Metastatic.-refractory
  • Squamous cell carcinoma of the head and neck

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Gilbert, J., Cmelak, A., Shyr, Y., Netterville, J., Burkey, B. B., Sinard, R. J., ... Murphy, B. A. (2008). Phase II trial of irinotecan plus cisplatin in patients with recurrent or metastatic squamous carcinoma of the head and neck. Cancer, 113(1), 186-192. https://doi.org/10.1002/cncr.23545

Phase II trial of irinotecan plus cisplatin in patients with recurrent or metastatic squamous carcinoma of the head and neck. / Gilbert, Jill; Cmelak, Anthony; Shyr, Yu; Netterville, James; Burkey, Brian B.; Sinard, Robert J.; Yarbrough, Wendall G.; Chung, Christine H.; Aulino, Joseph M.; Murphy, Barbara A.

In: Cancer, Vol. 113, No. 1, 01.07.2008, p. 186-192.

Research output: Contribution to journalArticle

Gilbert, J, Cmelak, A, Shyr, Y, Netterville, J, Burkey, BB, Sinard, RJ, Yarbrough, WG, Chung, CH, Aulino, JM & Murphy, BA 2008, 'Phase II trial of irinotecan plus cisplatin in patients with recurrent or metastatic squamous carcinoma of the head and neck', Cancer, vol. 113, no. 1, pp. 186-192. https://doi.org/10.1002/cncr.23545
Gilbert, Jill ; Cmelak, Anthony ; Shyr, Yu ; Netterville, James ; Burkey, Brian B. ; Sinard, Robert J. ; Yarbrough, Wendall G. ; Chung, Christine H. ; Aulino, Joseph M. ; Murphy, Barbara A. / Phase II trial of irinotecan plus cisplatin in patients with recurrent or metastatic squamous carcinoma of the head and neck. In: Cancer. 2008 ; Vol. 113, No. 1. pp. 186-192.
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abstract = "BACKGROUND. Patients with recurrent or metastatic HNC have a poor response and survival with currently available chemotherapy agents. Thus, new agents are needed. The authors report the results of a phase II trial of irinotecan and cisplatin in patients with metastatic or recurrent HNC. METHODS. Patients were treated with irinotecan 65 mg/m2 IV over 90 minutes and cisplatin 30 mg/m2 were administered intravenously weekly for four weeks, followed by a two week rest. However, after 17 patients were treated with weekly irinotecan at a dose of 65 mg/m2, toxicity analysis demonstrated the poor tolerance of that dose in this patient population. Thus, the protocol was amended, and irinotecan was dose reduced to a starting dose of 50 mg/m 2. Twenty-three additional patients were treated with this dose. RESULTS. Forty patients were enrolled on study between February 2002 and April 2006, 17 patients at the first dose level and 23 patients at the amended dose level. Overall, 12 of 17 patients (71{\%}) treated with irinotecan 65 mg/m 2 experienced clinically significant grade 3 or 4 toxicity. Twelve patients required dose reductions. Toxicity was reduced but 17{\%} of patients still experienced grade 3 or 4 toxicity on the lower irinotecan dose. The response rate was 35{\%} for patients treated at irinotecan 65 mg/m2 and 22{\%} for patients treated at 50 mg/m2. No complete responses were noted. CONCLUSIONS. The combination of irinotecan and cisplatin is efficacious in a poor prognosis group of patients but toxicity is substantial.",
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T1 - Phase II trial of irinotecan plus cisplatin in patients with recurrent or metastatic squamous carcinoma of the head and neck

AU - Gilbert, Jill

AU - Cmelak, Anthony

AU - Shyr, Yu

AU - Netterville, James

AU - Burkey, Brian B.

AU - Sinard, Robert J.

AU - Yarbrough, Wendall G.

AU - Chung, Christine H.

AU - Aulino, Joseph M.

AU - Murphy, Barbara A.

PY - 2008/7/1

Y1 - 2008/7/1

N2 - BACKGROUND. Patients with recurrent or metastatic HNC have a poor response and survival with currently available chemotherapy agents. Thus, new agents are needed. The authors report the results of a phase II trial of irinotecan and cisplatin in patients with metastatic or recurrent HNC. METHODS. Patients were treated with irinotecan 65 mg/m2 IV over 90 minutes and cisplatin 30 mg/m2 were administered intravenously weekly for four weeks, followed by a two week rest. However, after 17 patients were treated with weekly irinotecan at a dose of 65 mg/m2, toxicity analysis demonstrated the poor tolerance of that dose in this patient population. Thus, the protocol was amended, and irinotecan was dose reduced to a starting dose of 50 mg/m 2. Twenty-three additional patients were treated with this dose. RESULTS. Forty patients were enrolled on study between February 2002 and April 2006, 17 patients at the first dose level and 23 patients at the amended dose level. Overall, 12 of 17 patients (71%) treated with irinotecan 65 mg/m 2 experienced clinically significant grade 3 or 4 toxicity. Twelve patients required dose reductions. Toxicity was reduced but 17% of patients still experienced grade 3 or 4 toxicity on the lower irinotecan dose. The response rate was 35% for patients treated at irinotecan 65 mg/m2 and 22% for patients treated at 50 mg/m2. No complete responses were noted. CONCLUSIONS. The combination of irinotecan and cisplatin is efficacious in a poor prognosis group of patients but toxicity is substantial.

AB - BACKGROUND. Patients with recurrent or metastatic HNC have a poor response and survival with currently available chemotherapy agents. Thus, new agents are needed. The authors report the results of a phase II trial of irinotecan and cisplatin in patients with metastatic or recurrent HNC. METHODS. Patients were treated with irinotecan 65 mg/m2 IV over 90 minutes and cisplatin 30 mg/m2 were administered intravenously weekly for four weeks, followed by a two week rest. However, after 17 patients were treated with weekly irinotecan at a dose of 65 mg/m2, toxicity analysis demonstrated the poor tolerance of that dose in this patient population. Thus, the protocol was amended, and irinotecan was dose reduced to a starting dose of 50 mg/m 2. Twenty-three additional patients were treated with this dose. RESULTS. Forty patients were enrolled on study between February 2002 and April 2006, 17 patients at the first dose level and 23 patients at the amended dose level. Overall, 12 of 17 patients (71%) treated with irinotecan 65 mg/m 2 experienced clinically significant grade 3 or 4 toxicity. Twelve patients required dose reductions. Toxicity was reduced but 17% of patients still experienced grade 3 or 4 toxicity on the lower irinotecan dose. The response rate was 35% for patients treated at irinotecan 65 mg/m2 and 22% for patients treated at 50 mg/m2. No complete responses were noted. CONCLUSIONS. The combination of irinotecan and cisplatin is efficacious in a poor prognosis group of patients but toxicity is substantial.

KW - Cisplatin

KW - Concurrent chemoradiotherapy

KW - Irinotecan

KW - Metastatic.-refractory

KW - Squamous cell carcinoma of the head and neck

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