A north central cancer treatment group phase II trial of 9-aminocamptothecin in previously untreated patients with measurable metastatic colorectal carcinoma

Henry C. Pitot, James A. Knost, Michelle R. Mahoney, John Kugler, James E. Krook, Alan K. Hatfield, Daniel J. Sargent, Richard M. Goldberg

Research output: Contribution to journalArticle

16 Scopus citations

Abstract

BACKGROUND. Topoisomerase I inhibitors have demonstrated clinical activity in patients with metastatic colorectal carcinoma. The authors performed a Phase II study to evaluate the objective tumor response rate of 2 different doses and schedules of 9-aminocamptothecin (9-AC) in previously untreated patients with measurable recurrent metastatic colorectal carcinoma. METHODS. Fifty-one patients were registered. One schedule evaluated 9-AC given at 1100 μg/m2/24 hours by continuous infusion for 72 hours along with granulocyte-colony stimulating factor at 5 μg/kg/day on Days 5 through 12. Another schedule involved 9-AC at 480 μg/m2/24 hours by continuous infusion for 120 hours on Days 1, 8, and 15 given every 4 weeks. RESULTS. Forty-eight of 51 patients (94%) were evaluable (28 patients who received 72-hour infusion and 20 patients who received 120-hour infusion) for response and toxicity. Significant hematologic toxicities were encountered, especially with the 72-hour infusion schedule, in which 43% (12 of 28) and 28% (8 of 28) experienced Grade 4 (National Cancer Institute Common Toxicity Criteria) leukopenia and thrombocytopenia, respectively. Grade 4 neutropenia was encountered in 61% (17 of 28) and 11% (2 of 19) of patients on the 72-hour and 120-hour infusion schedules, respectively. Diarrhea, nausea, vomiting, and hepatotoxicity were troublesome nonhematologic toxicities. Seventy-nine percent (11 of 14) and 57% (4 of 7) of the patients experiencing Grade 3 or 4 nonhematologic toxicity were on the 72-hour infusion schedule. Three patients died of chemotherapy-related toxicity. One response was observed in 48 evaluable patients (2%). CONCLOSIONS. 9-AC did not demonstrate sufficient antitumor activity and had unacceptable toxicity in previously untreated patients with metastatic colorectal carcinoma. (C) 2000 American Cancer Society.

Original languageEnglish (US)
Pages (from-to)1699-1705
Number of pages7
JournalCancer
Volume89
Issue number8
DOIs
StatePublished - Oct 15 2000

Keywords

  • 9-aminocamptothecin
  • Colorectal carcinoma
  • Metastatic
  • Phase II

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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