Phase I studies of continuous-infusion paclitaxel given with standard aggressive radiation therapy for locally advanced solid tumors

Semin Oncol. 1995 Aug;22(4 Suppl 9):13-7.

Abstract

Currently available therapies are unsatisfactory for locally advanced solid tumors of the lung, head and neck, and brain. Laboratory data suggest that the addition of paclitaxel (Taxol; Bristol-Myers Squibb Oncology, Princeton, NJ), a microtubule-stabilizing drug, to radiation therapy may result in significant radiation sensitization, perhaps because paclitaxel induces cell cycle arrest at G2/M. Relatively low concentrations, 1 to 10 nmol/L, appear to be optimal for direct cytotoxicity and radiosensitization in vitro. Within this dose range, more prolonged exposure seems to result in higher response rates. We are conducting phase I trials designed to test continuous infusion (24 hours per day, 7 days per week) intravenous paclitaxel combined with standard curative-intent radiation therapy. To date, 22 patients are evaluable, and the maximum tolerated dose of paclitaxel has not been reached at up to 2.5 mg/m2/d. Observed toxicities include anemia, lymphopenia, mucositis, and cutaneous erythema/desquamation.

Publication types

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

MeSH terms

  • Anemia / chemically induced
  • Brain Neoplasms / drug therapy
  • Brain Neoplasms / radiotherapy*
  • Carcinoma, Non-Small-Cell Lung / drug therapy
  • Carcinoma, Non-Small-Cell Lung / radiotherapy*
  • Carcinoma, Squamous Cell / drug therapy
  • Carcinoma, Squamous Cell / radiotherapy*
  • Cell Cycle / drug effects
  • Combined Modality Therapy
  • Dose-Response Relationship, Drug
  • Female
  • Glioblastoma / drug therapy
  • Glioblastoma / radiotherapy*
  • Head and Neck Neoplasms / drug therapy
  • Head and Neck Neoplasms / radiotherapy*
  • Humans
  • Infusions, Intravenous
  • Lung Neoplasms / drug therapy
  • Lung Neoplasms / radiotherapy*
  • Lymphopenia / chemically induced
  • Paclitaxel / administration & dosage
  • Paclitaxel / adverse effects
  • Paclitaxel / therapeutic use*
  • Radiation-Sensitizing Agents / therapeutic use
  • Remission Induction
  • Uterine Cervical Neoplasms / drug therapy
  • Uterine Cervical Neoplasms / radiotherapy*

Substances

  • Radiation-Sensitizing Agents
  • Paclitaxel