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 language | English |
|---|---|
| Pages (from-to) | 85-89 |
| Number of pages | 5 |
| Journal | American Journal of Clinical Oncology: Cancer Clinical Trials |
| Volume | 29 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Feb 2006 |
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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 journal › Article
}
TY - JOUR
T1 - Capecitabine plus weekly oxaliplatin in gastrointestinal tumors
T2 - A phase I study
AU - Carlomagno, Chiara
AU - Orditura, Michele
AU - Pepe, Stefano
AU - De Vita, Ferdinando
AU - Romano, Carmela
AU - Ciardiello, Fortunato
AU - Ferrara, Claudia
AU - Martinelli, Erika
AU - Bianco, Roberto
AU - Aurilio, Gaetano
AU - D'Agostino, Diego
AU - Tortora, Giampaolo
AU - Catalano, Giuseppe
AU - De Placido, Sabino
PY - 2006/2
Y1 - 2006/2
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.
AB - 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.
KW - Capecitabine
KW - Oxaliplatin
KW - Phase I
UR - http://www.scopus.com/inward/record.url?scp=33644869705&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=33644869705&partnerID=8YFLogxK
U2 - 10.1097/01.coc.0000195087.24930.e7
DO - 10.1097/01.coc.0000195087.24930.e7
M3 - Article
VL - 29
SP - 85
EP - 89
JO - American Journal of Clinical Oncology
JF - American Journal of Clinical Oncology
SN - 0277-3732
IS - 1
ER -