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  • Title: Phase I study of BW12C in combination with mitomycin C in patients with advanced gastrointestinal cancer.
    Author: Ramsay JR, Bleehen NM, Dennis I, Workman P, Ward R, Falk SJ, Bedford P, Wootton R, Nethersell AB.
    Journal: Int J Radiat Oncol Biol Phys; 1992; 22(4):721-5. PubMed ID: 1544845.
    Abstract:
    The effect of combining the oxyhemoglobin-modifying drug BW12C with mitomycin C was investigated in a Phase I study of 18 patients with advanced gastrointestinal cancer. The dose of BW12C was increased from 20 mg/kg to 50 mg/kg to modify the hemoglobin-oxygen saturation curve by up to 48%. The period of maximum modification was then prolonged for up to 3 hr by a maintenance infusion of 4-6 mg/kg/hr. Pharmacokinetics of BW12C and mitomycin C were performed in all patients. Peak levels of BW12C increased from 139 micrograms/ml to 378 micrograms/ml. Plasma half life was independent of dose, with an average of 3.3 hr. BW12C was well tolerated with no severe side effects. Three patients had objective tumour responses.
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