Phase I Study of CBT-1™ and Taxol® in Patients with Taxol® Resistant Cancers
Copyright policy )Phase I Study of CBT-1™ and Taxol® in Patients with Taxol® Resistant Cancers
CBT-1, a natural product, was studied as an MDR modulator with Taxol (135 mg/m2) in an escalating dose Phase I clinical trial. CBT-1 was administered orally at doses from 300 mg/m2 to 500 mg/m2 daily x 7. The MTD was determined to be 500 mg/m2 with moderate nausea and occasional emesis. Side effects were mainly attributable to Taxol rather than the study drug. A total of 18 patients were registered on study with only one patient determined to be intolerant of CBT-1 due to nausea and emesis. In this Phase I study four patients (3 breast, 1 NSCLC) remained stable for greater than two cycles of treatment. No complete or partial responses were seen in this Taxol resistant population of patients with advanced cancer.
Adult, Male, Salvage Therapy, Paclitaxel, Gastrointestinal Diseases, Middle Aged, Antineoplastic Agents, Phytogenic, Combined Modality Therapy, Drug Resistance, Multiple, Biological Factors, Alkaloids, Treatment Outcome, Drug Resistance, Neoplasm, Hyperpigmentation, Neoplasms, Humans, Female, Bone Marrow Diseases, Aged
Adult, Male, Salvage Therapy, Paclitaxel, Gastrointestinal Diseases, Middle Aged, Antineoplastic Agents, Phytogenic, Combined Modality Therapy, Drug Resistance, Multiple, Biological Factors, Alkaloids, Treatment Outcome, Drug Resistance, Neoplasm, Hyperpigmentation, Neoplasms, Humans, Female, Bone Marrow Diseases, Aged
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