Abstract
Purpose: This study evaluated the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of erlotinib when combined to irinotecan and capecitabine in pre-treated metastatic colorectal cancer patients. Methods: Five dose level combinations with irinotecan (from 180 to 240 mg/m2, day 1, q21), capecitabine (1,500-2,000 mg/m2 per day, days 2-15, q21) and erlotinib (50-150 mg per day, continuously) were planned. Patients were enrolled in cohorts of three, and evaluated for first cycle acute toxicity. Results: Twenty-one patients were treated. In the first cohort, no DLT was reported, in the second: one DLT (G4 neutropenic fever associated with G3 cutaneous rash and mucositis); in the third dose level: two DLT (G3 diarrhea and G4 neutropenic fever). To confirm these results, other six patients were additionally included and no DLT was observed. Conclusions: The results documented that erlotinib at the dose of 100 mg per day, irinotecan 180 mg/m2 and capecitabine 1,500 mg/m2 per day for 14 days has an acceptable safety profile and appears suitable for further phase II studies.
| Original language | English |
|---|---|
| Pages (from-to) | 67-72 |
| Number of pages | 6 |
| Journal | Cancer Chemotherapy and Pharmacology |
| Volume | 64 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Jun 2009 |
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Keywords
- Capecitabine
- Colorectal cancer
- Erlotinib
- Irinotecan
ASJC Scopus subject areas
- Cancer Research
- Oncology
- Pharmacology
- Pharmacology (medical)
- Toxicology
Cite this
Dose finding study of erlotinib combined to capecitabine and irinotecan in pretreated advanced colorectal cancer patients. / Bajetta, Emilio; Di Bartolomeo, Maria; Buzzoni, Roberto; Ferrario, Erminia; Dotti, Katia F.; Mariani, Luigi; Bajetta, Roberto; Gevorgyan, Arpine; Venturino, Paola; Galassi, Margherita.
In: Cancer Chemotherapy and Pharmacology, Vol. 64, No. 1, 06.2009, p. 67-72.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Dose finding study of erlotinib combined to capecitabine and irinotecan in pretreated advanced colorectal cancer patients
AU - Bajetta, Emilio
AU - Di Bartolomeo, Maria
AU - Buzzoni, Roberto
AU - Ferrario, Erminia
AU - Dotti, Katia F.
AU - Mariani, Luigi
AU - Bajetta, Roberto
AU - Gevorgyan, Arpine
AU - Venturino, Paola
AU - Galassi, Margherita
PY - 2009/6
Y1 - 2009/6
N2 - Purpose: This study evaluated the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of erlotinib when combined to irinotecan and capecitabine in pre-treated metastatic colorectal cancer patients. Methods: Five dose level combinations with irinotecan (from 180 to 240 mg/m2, day 1, q21), capecitabine (1,500-2,000 mg/m2 per day, days 2-15, q21) and erlotinib (50-150 mg per day, continuously) were planned. Patients were enrolled in cohorts of three, and evaluated for first cycle acute toxicity. Results: Twenty-one patients were treated. In the first cohort, no DLT was reported, in the second: one DLT (G4 neutropenic fever associated with G3 cutaneous rash and mucositis); in the third dose level: two DLT (G3 diarrhea and G4 neutropenic fever). To confirm these results, other six patients were additionally included and no DLT was observed. Conclusions: The results documented that erlotinib at the dose of 100 mg per day, irinotecan 180 mg/m2 and capecitabine 1,500 mg/m2 per day for 14 days has an acceptable safety profile and appears suitable for further phase II studies.
AB - Purpose: This study evaluated the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of erlotinib when combined to irinotecan and capecitabine in pre-treated metastatic colorectal cancer patients. Methods: Five dose level combinations with irinotecan (from 180 to 240 mg/m2, day 1, q21), capecitabine (1,500-2,000 mg/m2 per day, days 2-15, q21) and erlotinib (50-150 mg per day, continuously) were planned. Patients were enrolled in cohorts of three, and evaluated for first cycle acute toxicity. Results: Twenty-one patients were treated. In the first cohort, no DLT was reported, in the second: one DLT (G4 neutropenic fever associated with G3 cutaneous rash and mucositis); in the third dose level: two DLT (G3 diarrhea and G4 neutropenic fever). To confirm these results, other six patients were additionally included and no DLT was observed. Conclusions: The results documented that erlotinib at the dose of 100 mg per day, irinotecan 180 mg/m2 and capecitabine 1,500 mg/m2 per day for 14 days has an acceptable safety profile and appears suitable for further phase II studies.
KW - Capecitabine
KW - Colorectal cancer
KW - Erlotinib
KW - Irinotecan
UR - http://www.scopus.com/inward/record.url?scp=67349096951&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=67349096951&partnerID=8YFLogxK
U2 - 10.1007/s00280-008-0852-1
DO - 10.1007/s00280-008-0852-1
M3 - Article
C2 - 18936940
AN - SCOPUS:67349096951
VL - 64
SP - 67
EP - 72
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
SN - 0344-5704
IS - 1
ER -