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Phase I and pharmacologic study of the arotinoid Ro 40-8757 in combination with cisplatin and etoposide in patients with non-small cell lung cancer.

Abstract
This phase I study was performed to assess the feasibility of combining cisplatin/etoposide (VP-16) with the arotinoid Ro 40-8757 and to determine the dose-limiting toxicity (DLT) of Ro 40-8757 in this combination. Patients with non-small cell lung cancer were eligible. Treatment consisted of Ro 40-8757 p.o. day 1-21, cisplatin 100 mg/m2 i.v. on day 2 and VP-16 100 mg/m2 i.v. on day 2-4, repeated every 3 weeks. Eighteen patients were evaluable for toxicity and response. The doses of Ro 40-8757 ranged from 84 mg/m2 once daily to 42 mg/m2 thrice daily (tid). DLT consisting of delayed nausea/vomiting was reached at 42 mg/m2 tid. Consequently, the maximum tolerated dose was set at one dose level below the DLT, i.e. 28 mg/m2 tid. Skin toxicity occurred but was well manageable. Pharmacological analyses showed a small increase in the volume of distribution of cisplatin and VP-16 between the first and third course. However, no relationship with side effects was found. A response was achieved in 50% of patients. The combination of cisplatin/VP-16 with Ro 40-8757 appears to be feasible at a dose schedule of 28 mg/m2 tid. The response rate was at the upper rate of what can be expected with cisplatin and VP-16.
AuthorsL van Zuylen, J H Schellens, S H Goey, L C Pronk, M M de Boer-Dennert, W J Loos, J Ma, G Stoter, J Verweij
JournalAnti-cancer drugs (Anticancer Drugs) Vol. 10 Issue 4 Pg. 361-8 (Apr 1999) ISSN: 0959-4973 [Print] England
PMID10378670 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article)
Chemical References
  • Antineoplastic Agents
  • Morpholines
  • Retinoids
  • Etoposide
  • mofarotene
  • Cisplatin
Topics
  • Adult
  • Aged
  • Antineoplastic Agents (administration & dosage, adverse effects)
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects)
  • Carcinoma, Non-Small-Cell Lung (drug therapy)
  • Cisplatin (administration & dosage, adverse effects, pharmacokinetics)
  • Etoposide (administration & dosage, adverse effects, pharmacokinetics)
  • Female
  • Humans
  • Lung Neoplasms (drug therapy)
  • Male
  • Metabolic Clearance Rate
  • Middle Aged
  • Morpholines (administration & dosage, adverse effects, pharmacokinetics)
  • Retinoids (administration & dosage, adverse effects, pharmacokinetics)

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