Phase II study of protracted irinotecan infusion and a low-dose cisplatin for metastatic gastric cancer

World J Gastroenterol. 2006 Oct 28;12(40):6522-6. doi: 10.3748/wjg.v12.i40.6522.

Abstract

Aim: To test protracted irinotecan infusion plus a low-dose cisplatin in this Phase II trial to decrease its toxicity.

Methods: The eligibility criteria were: (1) histologically proven measurable gastric cancer; (2) performance status of 0 or 1; (3) no prior chemotherapy or completion of prior therapy at least 4 wk before enrollment; (4) adequate function of major organs; (5) no other active malignancy; and (6) written informed consent. The regimen consisted of irinotecan (60 mg/m(2)) on d 1 and 15 by 24-h infusion and cisplatin (10 mg/m(2)) on d 1, 2, 3, 15, 16, and 17. Treatment was repeated every 4 wk.

Results: Thirty-one patients were registered between April 2000 and January 2001. The response rate for all 31 patients, 20 patients without prior chemotherapy, and 11 patients with prior chemotherapy was 52% (16/31), 60% (12/20), and 36% (4/11), respectively. The median survival time was 378 d. The median number of courses given to all patients was 2. Grade 4 neutropenia occurred in 11 (35%) patients, while grade 3 to 4 diarrhea or nausea occurred in 1 (3%) and 3 (10%) patients, respectively. Fatigue was minimal as grade 1 fatigue was found only in 3 (10%) patients. Other adverse events were mild and no treatment-related deaths occurred.

Conclusion: This regimen showed a high level of activity and acceptable toxicity in patients with metastatic gastric cancer.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Camptothecin / administration & dosage
  • Camptothecin / analogs & derivatives
  • Cisplatin / administration & dosage
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Female
  • Humans
  • Infusions, Intravenous
  • Irinotecan
  • Male
  • Middle Aged
  • Neoplasm Metastasis / drug therapy*
  • Stomach Neoplasms / drug therapy*
  • Survival Rate
  • Treatment Outcome

Substances

  • Irinotecan
  • Cisplatin
  • Camptothecin