A phase I study of carboplatin and paclitaxel in non-small cell lung cancer: a University of Colorado Cancer Center study

Semin Oncol. 1995 Aug;22(4 Suppl 9):2-6.

Abstract

This phase I study was designed to determine the maximal tolerated doses of carboplatin and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), as well as the safety and efficacy of these agents, in patients with advanced, nonresectable stages IIIB and IV non-small cell lung cancer. Paclitaxel was given as a 3-hour intravenous infusion followed by a 30-minute infusion of carboplatin. Patients were assigned to one of seven treatment groups in which paclitaxel and carboplatin were given in doses ranging from 135 to 225 mg/m2 and from 250 to 400 mg/m2, respectively. Overall, the two-drug combination has been well tolerated. The major dose-limiting toxicity has not been reached but will likely be neutropenia. There appears to be a dose-response relationship: two partial responses (12%) were observed among 17 patients assigned to the lower-dose groups, whereas six (50%) of 12 evaluable patients in the higher-dose groups achieved partial responses. The maximal tolerated doses have not been reached yet, and will be at least 200 mg/m2 for paclitaxel and 400 mg/m2 for carboplatin.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I
  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Carboplatin / administration & dosage*
  • Carboplatin / adverse effects
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Colorado
  • Dose-Response Relationship, Drug
  • Drug Tolerance
  • Female
  • Humans
  • Infusions, Intravenous
  • Lung Neoplasms / drug therapy*
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Neutropenia / chemically induced
  • Paclitaxel / administration & dosage*
  • Paclitaxel / adverse effects
  • Remission Induction
  • Safety

Substances

  • Carboplatin
  • Paclitaxel