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A phase I/II study of a hypoxic cell radiosensitizer KU-2285 in combination with intraoperative radiotherapy.

Abstract
A fluorinated 2-nitroimidazole radiosensitizer KU-2285 was given before intraoperative radiotherapy (IORT) to 30 patients with unresectable, unresected or macroscopic residual tumours. Twenty-three patients had pancreatic cancer and five had osteosarcoma. The IORT dose was 30 Gy for unresectable pancreatic cancer and 60 Gy for osteosarcoma. The dose of KU-2285 administered ranged from 1 to 9 g m-2. Four patients received a dose of 9 g m-2, and ten received 6.8-7 g m-2. All patients tolerated KU-2285 well, and no drug-related toxicity was observed. The average tumour concentration of KU-2285 immediately after IORT was 166 microg g-1 at dose of 6.8-7 g m-2 and 333 microg g-1 at 9 g m-2. The average tumour-plasma ratio was > or = 0.82. Eleven patients with unresectable but localized pancreatic cancer treated with KU-2285 plus IORT and external beam radiotherapy had a median survival time of 11 months and 1-year local control rate of 50%, which compares favourably with those of 8 months (P = 0.26) and 28% (P = 0.10) for 22 matched historical control patients. The five patients with osteosarcoma attained local control. The results of this first study on KU-2285 and IORT appear encouraging, and further studies of this compound seem to be warranted.
AuthorsY Shibamoto, G Ohshio, R Hosotani, Y Nishimura, T Manabe, M Imamura, M Abe
JournalBritish journal of cancer (Br J Cancer) Vol. 76 Issue 11 Pg. 1474-9 ( 1997) ISSN: 0007-0920 [Print] England
PMID9400944 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article)
Chemical References
  • Nitroimidazoles
  • Radiation-Sensitizing Agents
  • KU 2285
Topics
  • Adolescent
  • Adult
  • Aged
  • Bone Neoplasms (radiotherapy, surgery)
  • Child
  • Combined Modality Therapy
  • Female
  • Humans
  • Intraoperative Care
  • Male
  • Middle Aged
  • Nitroimidazoles (adverse effects, pharmacokinetics, therapeutic use)
  • Osteosarcoma (radiotherapy, surgery)
  • Pancreatic Neoplasms (radiotherapy, surgery)
  • Radiation-Sensitizing Agents (adverse effects, pharmacokinetics, therapeutic use)
  • Treatment Outcome

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