A phase II study of topotecan administered five times daily in patients with advanced gastric cancer Journal Article


Authors: Saltz, L. B.; Schwartz, G. K.; Ilson, D. H.; Quan, V.; Kelsen, D. P.
Article Title: A phase II study of topotecan administered five times daily in patients with advanced gastric cancer
Abstract: Objective: Topotecan (Tpt), a semisynthetic analogue of camptothecin (Cpt), has shown excellent preclinical activity in a number of solid tumors. Cpt, the parent compound, has preclinical activity against several gastrointestinal tumors, including a gastric adenocarcinoma xenograft. A phase-II clinical trial was conducted to assess the activity of Tpt in patients with advanced gastric cancer. Materials and Methods: 15 patients with advanced, incurable gastric adenocarcinomas were treated. Tpt 1.5 (mg/m2/day) was administered intravenously as a 30-min infusion dally for 5 consecutive days. Treatments were repeated on a 21-day cycle. Results: No major objective responses were observed in 13 evaluable patients (response rate = 0%; 95% confidence interval = 0-22%). The major dose-limiting toxicity in this trial was myelosuppression, which was severe in this patient population. Conclusions: Tpt at the dose and schedule studied does not possess substantial antitumor activity in patients with gastric cancer, and the toxicities were formidable. We do not advocate further development of this drug in the treatment of gastric cancer. Tpt has shown more promising activity and tolerability in other patient populations, and these areas deserve further exploration.
Keywords: adult; cancer chemotherapy; cancer survival; clinical article; treatment outcome; aged; middle aged; clinical trial; antineoplastic agents; topotecan; antineoplastic agent; phase 2 clinical trial; bone marrow suppression; nausea; drug administration schedule; camptothecin; stomach cancer; camptothecin derivative; stomach adenocarcinoma; granulocyte colony-stimulating factor; stomach neoplasms; intravenous drug administration; gastric cancer; phase ii study; humans; human; male; female; article
Journal Title: American Journal of Clinical Oncology
Volume: 20
Issue: 6
ISSN: 0277-3732
Publisher: Lippincott Williams & Wilkins  
Date Published: 1997-12-01
Start Page: 621
End Page: 625
Language: English
DOI: 10.1097/00000421-199712000-00018
PUBMED: 9391553
PROVIDER: scopus
DOI/URL:
Notes: Article -- Export Date: 17 March 2017 -- Source: Scopus
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  1. Leonard B Saltz
    790 Saltz
  2. Gary Schwartz
    385 Schwartz
  3. David H Ilson
    433 Ilson
  4. David P Kelsen
    537 Kelsen
  5. Valerie L Quan
    3 Quan