Summary
The ether lipid miltefosine (hexadecylphosphocholine) was orally given to patients with various tumours in a dose-finding study. All patients initially received a daily total dose of 100 mg, which in the absence of side-effects was increased to 150 mg and further to 200 mg. A total of 54 patients were entered and were evaluable for gastrointestinal toxicity. Nausea and vomiting were found to be dose-limiting; 22% of patients ultimately tolerated a dose of 100 mg, 59% tolerated a dose of 150 mg and 19% tolerated a dose of 200 mg. In addition 30% of patients developed renal dysfunction, which was thought to be related to the drug. No other toxities were observed. For further phase II studies it is recommended that one starts with a dose of 150 mg daily, divided over three administrations.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Breiser A, Kim DJ, Fleer EAM, Damenz W, Drube A, Berger M, Nagel GA, Eibl H, Unger C (1987) Distribution and metabolism of hexadecylphosphocholine in mice. Lipids 22:925–926
Eibl H, Unger C, Berger M (1988) Characterization of the antitumor activity of hexadecylphosphocholine (D:8506). Eur J Cancer Clin Oncol 24:1457–1461
Fleer EAM, Unger C, Kim DJ, Eibl H (1987) Metabolism of ether phospholipids and analogs in neoplastic cells. Lipids 22:856–861
Planting A, Verweij J, Hoff A, Dees A, Seynaeve C, Stoter G (1990) Phase II study of daily oral hexadecylphosphocholine in advanced colorectal cancer. Ann Oncol 1 [Suppl]:46
Scherf HR, Schuler B, Berger MR, Schmähl D (1987) Therapeutic activity of ET-18-OCH3 and hexadecylphosphocholine against mammary tumors in BD-VI rats. Lipids 22:927–929
Unger C, Eibl H, Nagel GA, Heyden HW von, Breiser A, Engel J, Stekar J, Peukert M, Hilgard P, Berger M (1989a) Hexadecyl-phosphocholine in the topical treatment of skin metastases: a phase I trial. Contrib Oncol 37:219–223
Unger C, Damenz W, Fleer EAM, Kim DJ, Breiser A, Hilgard P, Engel J, Magel A, Eibl H (1989b) Hexadecylphosphocholine, a new ether lipid analogue. Studies on the antineoplastic activity in vitro and in vivo. Acta Oncol 28:213–217
Unger C, Eibl HJ, Heyden HW von, Peukert M, Sindermann H, Nagel G (1990) Phase I study with daily hexadecylphosphocholine in patients with malignant disease (abstract). J Cancer Res Clin Oncol 116:993
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Verweij, J., Planting, A., van der Burg, M. et al. A dose-finding study of miltefosine (hexadecylphosphocholine) in patients with metastatic solid tumours. J Cancer Res Clin Oncol 118, 606–608 (1992). https://doi.org/10.1007/BF01211805
Received:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/BF01211805