Phase II study of capecitabine and mitomycin C as first-line treatment in patients with advanced colorectal cancer

Br J Cancer. 2004 Aug 31;91(5):839-43. doi: 10.1038/sj.bjc.6602039.

Abstract

This study was designed to assess the safety and efficacy of capecitabine and mitomycin C (MMC) in previously untreated patients with advanced colorectal cancer (CRC). Patients received capecitabine 2500 mg m(2) day 1, orally divided in two doses of 1250 mg m(-2) in the morning and evening for 14 days every 21 days and MMC 7 mg m(-2) (maximum total dose 14 mg) as an intravenous bolus every 6 weeks for a total of four courses. The median age was 70 years (range 24-85) and the majority of patients (86.9%) were of performance status 1/2. The most common metastatic site was liver. In all, 84 patients were assessable for response. The overall response rate was 38% (95% CI: 27.7-49.3) and a further 33.3% of patients achieved stable disease over 12 weeks. There was good symptom resolution ranging from 64 to 86%. Grade 3/4 toxicity was as follows: hand-foot syndrome 19.7%; diarrhoea 10%; neutropenia 2.4%; infection 2.3%. Capecitabine and MMC have shown encouraging activity with a favourable toxicity profile, a convenient administration schedule, and could be considered for patients deemed unsuitable for oxaliplatin and irinotecan combinations.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols
  • Capecitabine
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / mortality
  • Colorectal Neoplasms / pathology
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / therapeutic use*
  • Dose-Response Relationship, Drug
  • Female
  • Fluorouracil / analogs & derivatives
  • Humans
  • Liver Neoplasms / drug therapy
  • Liver Neoplasms / mortality
  • Liver Neoplasms / secondary
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Mitomycin / adverse effects
  • Mitomycin / therapeutic use*
  • Survival Analysis
  • Treatment Outcome

Substances

  • Antineoplastic Agents
  • Deoxycytidine
  • Mitomycin
  • Capecitabine
  • Fluorouracil