Phase II trial of irinotecan plus docetaxel in cisplatin-pretreated relapsed or refractory oesophageal cancer

Br J Cancer. 2003 Aug 18;89(4):630-3. doi: 10.1038/sj.bjc.6601168.

Abstract

This phase II trial assessed the toxicity and efficacy of irinotecan plus docetaxel in cisplatin-pretreated oesophageal cancer. Irinotecan 160 mg m(-2) plus docetaxel 65 mg m(-2) once every 3 weeks led to severe myelosuppression in four patients, all of whom experienced neutropenic fever. After amendment of this regimen, 24 patients (male/female=18/6; median age=58.5 years; ECOG performance status 0/1/2=9/11/4) with advanced oesophageal cancer (adenocarcinoma/epidermoid carcinoma=13/11) received irinotecan 55 mg m(-2) plus docetaxel 25 mg m(-2) on days 1, 8 and 15 of a 28-day cycle. Serious adverse events occurred in five patients, one with lethal outcome (pneumonia). Haematological toxicity >or=3 degrees was rare, whereas nonhaematological toxicity >or=3 degrees was noted in nine out of 24 patients (asthenia in five patients, diarrhoea in three patients, nausea/emesis in two patients, constipation in one patient). Median survival time was 26 (range 2-70) weeks. Response rate, assessed according to the WHO criteria, was 12.5% (95% CI 2.7-32.4%); rate of disease stabilisation (partial remission and stable disease) was 33.3% (95% CI 15.6-55.3%) with a median duration of 18.5 (range 16-51) weeks. Although the nonhaematological toxicity proved to be considerable, weekly irinotecan plus docetaxel is feasible and shows some activity in extensively pretreated patients with oesophageal cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / secondary
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Camptothecin / administration & dosage
  • Camptothecin / analogs & derivatives*
  • Carcinoma, Squamous Cell / drug therapy
  • Carcinoma, Squamous Cell / secondary
  • Cisplatin / administration & dosage
  • Docetaxel
  • Dose-Response Relationship, Drug
  • Esophageal Neoplasms / drug therapy*
  • Esophageal Neoplasms / pathology
  • Female
  • Humans
  • Infusions, Intravenous
  • Irinotecan
  • Male
  • Maximum Tolerated Dose
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy*
  • Neoplasm Recurrence, Local / pathology
  • Paclitaxel / administration & dosage
  • Paclitaxel / analogs & derivatives*
  • Salvage Therapy
  • Survival Rate
  • Taxoids*
  • Treatment Outcome

Substances

  • Taxoids
  • Docetaxel
  • Irinotecan
  • Paclitaxel
  • Cisplatin
  • Camptothecin