Capecitabine, oxaliplatin and radiotherapy: a phase IB neoadjuvant study for esophageal cancer with gene expression analysis.
OBJECTIVE
To determine the maximal tolerated dose of capecitabine with oxaliplatin + radiotherapy in a phase I study of localized esophageal cancer.


METHODS
Oxaliplatin (85 mg/m(2)) administered on days 1, 15, and 29. Capecitabine administered twice daily 5 days weekly; dose levels (DL) were 1, 1000; 2, 1250; and 3, 1500 mg/m(2) with 50.4 Gy radiation.


RESULTS
Dose-limiting toxicity was reached at DL 3. Carboxylesterase expression in day 2 tumor specimens and induction correlated with response (p <or= 0.05).


CONCLUSIONS
The maximal tolerated dose was 85 mg/m(2) of oxaliplatin, 1,250 mg/m(2)/day of capecitabine, and 50.4 Gy of radiation.
Javle
Milind M
MM
Department of Gastrointestinal Medical Oncology, UT-MD Anderson Cancer Institute, Houston, Texas, USA. mjavle@mdanderson.org
Yang
Gary
G
Nwogu
Chumy E
CE
Wilding
Gregory E
GE
O'Malley
Linda
L
Vinjamaram
Sanjay
S
Schiff
Michael D
MD
Nava
Hector R
HR
LeVea
Charles
C
Clark
Kimberly R
KR
Prey
Joshua D
JD
Smith
Patrick F
PF
Pendyala
Lakshmi
L
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000069287:Capecitabine; D043182:Carboxylesterase / Q000235:genetics; D003131:Combined Modality Therapy; D003564:Cytidine Deaminase / Q000235:genetics; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000493:pharmacokinetics; D004938:Esophageal Neoplasms / Q000378:metabolism / Q000628:therapy*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000493:pharmacokinetics; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D000077150:Oxaliplatin; D013939:Thymidine Phosphorylase / Q000235:genetics
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D013939:Thymidine Phosphorylase; D043182:Carboxylesterase; D003564:Cytidine Deaminase; D005472:Fluorouracil