Capecitabine, oxaliplatin and radiotherapy: a phase IB neoadjuvant study for esophageal cancer with gene expression analysis.

Abstract

PURPOSE:

To determine the maximal tolerated dose of capecitabine with oxaliplatin + radiotherapy in a phase I study of localized esophageal cancer.

PATIENTS AND 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).

CONCLUSION:

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.

• Authors: Milind M Javle, Gary Yang, Chumy E Nwogu, Gregory E Wilding, Linda O'Malley, Sanjay Vinjamaram, Michael D Schiff, Hector R Nava, Charles LeVea, Kimberly R Clark, Joshua D Prey, Patrick F Smith, Lakshmi Pendyala
• Journal: Cancer investigation (Cancer Invest) Vol. 27 Issue 2 Pg. 193-200 (Feb 2009) ISSN: 1532-4192 [Electronic] England
• PMID: 19235592 (Publication Type: Clinical Trial, Phase I, Journal Article)

Chemical References

• Organoplatinum Compounds
• Oxaliplatin
• Deoxycytidine
• Capecitabine
• Thymidine Phosphorylase
• Carboxylesterase
• Cytidine Deaminase
• Fluorouracil

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Capecitabine
• Carboxylesterase (genetics)
• Combined Modality Therapy
• Cytidine Deaminase (genetics)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives, pharmacokinetics)
• Esophageal Neoplasms (metabolism, therapy)
• Female
• Fluorouracil (administration & dosage, adverse effects, analogs & derivatives, pharmacokinetics)
• Humans
• Male
• Middle Aged
• Organoplatinum Compounds (administration & dosage, adverse effects, pharmacokinetics)
• Oxaliplatin
• Thymidine Phosphorylase (genetics)