Capecitabine plus weekly oxaliplatin in gastrointestinal tumors: a phase I study.
OBJECTIVE
To investigate the maximum tolerated dose (MTD) and the dose-limiting toxicity (DLT) of capecitabine plus oxaliplatin.


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/m2 + oxaliplatin 50 mg/m2; 2) capecitabine 2000 mg/m2 + oxaliplatin 50 mg/m2; 3) capecitabine 2000 mg/m2 + oxaliplatin 60 mg/m2; and 4) capecitabine 2500 mg/m2 + oxaliplatin 60 mg/m2. 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 > or =3 nonhematological toxicity occurred in 3 patients, and hematological toxicity was sporadic.


CONCLUSIONS
This study demonstrates that clinically relevant doses of capecitabine (2000 mg/m2 from day 1 to 14) plus oxaliplatin (60 mg/m2 on days 1 and 8) every 3 weeks can be given without causing unacceptable toxicity.
Carlomagno
Chiara
C
Dipartimento di Endocrinologia ed Oncologia Molecolare e Clinica, Università di Napoli Federico II, Napoli, Italy.
Orditura
Michele
M
Pepe
Stefano
S
De Vita
Ferdinando
F
Romano
Carmela
C
Ciardiello
Fortunato
F
Ferrara
Claudia
C
Martinelli
Erika
E
Bianco
Roberto
R
Aurilio
Gaetano
G
D'Agostino
Diego
D
Tortora
Giampaolo
G
Catalano
Giuseppe
G
De Placido
Sabino
S
D000284:Administration, Oral; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil