Capecitabine plus weekly oxaliplatin in gastrointestinal tumors

A phase I study

Chiara Carlomagno, Michele Orditura, Stefano Pepe, Ferdinando De Vita, Carmela Romano, Fortunato Ciardiello, Claudia Ferrara, Erika Martinelli, Roberto Bianco, Gaetano Aurilio, Diego D'Agostino, Giampaolo Tortora, Giuseppe Catalano, Sabino De Placido

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

OBJECTIVE: To investigate the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of capecitabine plus oxaliplatin. MATERIALS AND METHODS: Oxaliplatin was given by 2-hour iv infusion on days 1 and 8, and capecitabine was given orally, from day 1 to 14, every 3 weeks. We tested 4 levels of doses: 1) capecitabine 1650 mg/m + oxaliplatin 50 mg/m; 2) capecitabine 2000 mg/m + oxaliplatin 50 mg/m; 3) capecitabine 2000 mg/m + oxaliplatin 60 mg/m; and 4) capecitabine 2500 mg/m + oxaliplatin 60 mg/m. Patients with gastrointestinal neoplasm were eligible for the study. RESULTS: Thirty-two patients were enrolled. At dose level 4, 3 patients had unacceptable toxicity (grade 3 diarrhea, grade 4 diarrhea, and grade 3 mucositis, respectively), thus, level 4 was the MTD. Apart from DLT, overall toxicity was mild: grade ≥3 nonhematological toxicity occurred in 3 patients, and hematological toxicity was sporadic. CONCLUSION: This study demonstrates that clinically relevant doses of capecitabine (2000 mg/m from day 1 to 14) plus oxaliplatin (60 mg/m on days 1 and 8) every 3 weeks can be given without causing unacceptable toxicity.

Original languageEnglish
Pages (from-to)85-89
Number of pages5
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Volume29
Issue number1
DOIs
Publication statusPublished - Feb 2006

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oxaliplatin
Neoplasms
Maximum Tolerated Dose
Diarrhea
Mucositis
Gastrointestinal Neoplasms
Capecitabine

Keywords

  • Capecitabine
  • Oxaliplatin
  • Phase I

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Capecitabine plus weekly oxaliplatin in gastrointestinal tumors : A phase I study. / Carlomagno, Chiara; Orditura, Michele; Pepe, Stefano; De Vita, Ferdinando; Romano, Carmela; Ciardiello, Fortunato; Ferrara, Claudia; Martinelli, Erika; Bianco, Roberto; Aurilio, Gaetano; D'Agostino, Diego; Tortora, Giampaolo; Catalano, Giuseppe; De Placido, Sabino.

In: American Journal of Clinical Oncology: Cancer Clinical Trials, Vol. 29, No. 1, 02.2006, p. 85-89.

Research output: Contribution to journalArticle

Carlomagno, C, Orditura, M, Pepe, S, De Vita, F, Romano, C, Ciardiello, F, Ferrara, C, Martinelli, E, Bianco, R, Aurilio, G, D'Agostino, D, Tortora, G, Catalano, G & De Placido, S 2006, 'Capecitabine plus weekly oxaliplatin in gastrointestinal tumors: A phase I study', American Journal of Clinical Oncology: Cancer Clinical Trials, vol. 29, no. 1, pp. 85-89. https://doi.org/10.1097/01.coc.0000195087.24930.e7
Carlomagno, Chiara ; Orditura, Michele ; Pepe, Stefano ; De Vita, Ferdinando ; Romano, Carmela ; Ciardiello, Fortunato ; Ferrara, Claudia ; Martinelli, Erika ; Bianco, Roberto ; Aurilio, Gaetano ; D'Agostino, Diego ; Tortora, Giampaolo ; Catalano, Giuseppe ; De Placido, Sabino. / Capecitabine plus weekly oxaliplatin in gastrointestinal tumors : A phase I study. In: American Journal of Clinical Oncology: Cancer Clinical Trials. 2006 ; Vol. 29, No. 1. pp. 85-89.
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AU - Romano, Carmela

AU - Ciardiello, Fortunato

AU - Ferrara, Claudia

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AU - Bianco, Roberto

AU - Aurilio, Gaetano

AU - D'Agostino, Diego

AU - Tortora, Giampaolo

AU - Catalano, Giuseppe

AU - De Placido, Sabino

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N2 - OBJECTIVE: To investigate the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of capecitabine plus oxaliplatin. MATERIALS AND METHODS: Oxaliplatin was given by 2-hour iv infusion on days 1 and 8, and capecitabine was given orally, from day 1 to 14, every 3 weeks. We tested 4 levels of doses: 1) capecitabine 1650 mg/m + oxaliplatin 50 mg/m; 2) capecitabine 2000 mg/m + oxaliplatin 50 mg/m; 3) capecitabine 2000 mg/m + oxaliplatin 60 mg/m; and 4) capecitabine 2500 mg/m + oxaliplatin 60 mg/m. Patients with gastrointestinal neoplasm were eligible for the study. RESULTS: Thirty-two patients were enrolled. At dose level 4, 3 patients had unacceptable toxicity (grade 3 diarrhea, grade 4 diarrhea, and grade 3 mucositis, respectively), thus, level 4 was the MTD. Apart from DLT, overall toxicity was mild: grade ≥3 nonhematological toxicity occurred in 3 patients, and hematological toxicity was sporadic. CONCLUSION: This study demonstrates that clinically relevant doses of capecitabine (2000 mg/m from day 1 to 14) plus oxaliplatin (60 mg/m on days 1 and 8) every 3 weeks can be given without causing unacceptable toxicity.

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