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.
Oldham
R K
RK
Cancer Treatment Associates, Franklin, TN 37068, USA.
Reid
W K
WK
Barnett
D
D
D000328:Adult; D000368:Aged; D000470:Alkaloids; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001685:Biological Factors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001855:Bone Marrow Diseases / Q000139:chemically induced; D003131:Combined Modality Therapy; D018432:Drug Resistance, Multiple; D019008:Drug Resistance, Neoplasm; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D017495:Hyperpigmentation / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy* / Q000628:therapy; D017239:Paclitaxel / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D016879:Salvage Therapy; D016896:Treatment Outcome
D000470:Alkaloids; D000972:Antineoplastic Agents, Phytogenic; D001685:Biological Factors; C412039:CBT-1 (plant alkaloid); D017239:Paclitaxel