title: Phase II evaluation of paclitaxel by short intravenous infusion in metastatic melanoma.
abstract: In four clinical trials in mostly chemotherapy-naive patients with metastatic melanoma, paclitaxel was found to be effective with a response rate of 16%. In vitro studies have shown that following exposure of cancer cells to paclitaxel for 1 h, sensitivity to repeat paclitaxel doses decreased markedly at 48-72 h and returned at 120 h. In this phase II study we assessed the efficacy of paclitaxel at a dose of 90 mg/m per day given intravenously over 80 min on days 1, 5 and 9 every 3 weeks, initially in two groups of 14 patients with metastatic choroidal and non-choroidal melanoma. One patient in the non-choroidal melanoma group had a confirmed response, and 23 additional patients were therefore accrued to this group. (One patient withdrew consent for treatment within a week from start of therapy. The patient was considered to have received inadequate treatment and a replacement was registered.) A total of 52 patients with a median age of 55 years (range 21-79 years) were treated. Forty-four patients completed two or more courses of paclitaxel and were evaluable for response. We observed >50% tumour regression in six patients. All the responses except one were amongst the 32 evaluable patients with non-choroidal melanoma. The response rate in this group was 15.6%. During the 219 courses of paclitaxel delivered, the side effects were mild, manageable and mostly reversible. No grade 3 acute allergic reactions were observed. Paclitaxel given by short intravenous infusion is marginally active against previously treated non-choroidal melanoma.
authors.affiliation: Department of Melanoma Medical Oncology, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 430, Houston, Texas, USA. abedikia@mdanderson.org
authors.forename: Agop Y
authors.initials: AY
authors.lastname: Bedikian
authors.forename: Carl
authors.initials: C
authors.lastname: Plager
authors.forename: Nicholas
authors.initials: N
authors.lastname: Papadopoulos
authors.forename: Omar
authors.initials: O
authors.lastname: Eton
authors.forename: Julie
authors.initials: J
authors.lastname: Ellerhorst
authors.forename: Theresa
authors.initials: T
authors.lastname: Smith
mesh_terms: D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D002830:Choroid Neoplasms / Q000188:drug therapy / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary*; D008297:Male; D020714:Maximum Tolerated Dose; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D012074:Remission Induction; D012878:Skin Neoplasms / Q000188:drug therapy / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D017239:Paclitaxel