Phase II study of Mitonafide in advanced and relapsed colorectal cancer.

Abstract

BACKGROUND:

This study investigated the antitumoral activity in colorectal cancer and toxicity of a 5-day continuous infusion of a new cytostatic agent, Mitonafide, that had previously shown to be neurotoxic when administered as a short daily x 5 days infusion.

PATIENTS AND METHODS:

Seventeen chemotherapy-naive patients with advanced or relapsed colorectal cancer and measurable disease entered the study. All but one received a 120-hour (5-day) continuous infusion of Mitonafide at a starting dose of 200 mg/m2/day every 3 weeks. Toxicity evaluation was performed after each course and response assessment every 2 courses using the standard World Health Organization (WHO) criteria completed by the "Mini-mental state" test for cognitive status examination.

RESULTS:

Sixteen patients received a total of 41 courses of Mitonafide which resulted to be severely myelotoxic. In total, 13/16 patients had WHO grade 3-4 neutropenia, 7 of them with infection, and the treatment had to be stopped in 3 patients after only 1 course due to excessive toxicity. No central nervous system toxicity was observed. No objective responses were evidenced.

CONCLUSIONS:

At the dose and schedule of administration used, Mitonafide is not active in colorectal cancer and induces severe myelotoxicity thus not deserving further studies in this indication.

• Authors: A Abad, C Grávalos, A Font, F Molina, M T Díaz-Puente, X Fabregat, A Benavides, M Martín
• Journal: Investigational new drugs (Invest New Drugs) Vol. 14 Issue 2 Pg. 223-5 ( 1996) ISSN: 0167-6997 [Print] United States
• PMID: 8913845 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Antineoplastic Agents
• Imides
• Isoquinolines
• Naphthalimides
• mitonafide

Topics

• Aged
• Antineoplastic Agents (adverse effects, therapeutic use)
• Colorectal Neoplasms (drug therapy)
• Female
• Humans
• Imides (adverse effects, therapeutic use)
• Isoquinolines (adverse effects, therapeutic use)
• Male
• Middle Aged
• Naphthalimides