Phase II evaluation of paclitaxel by short intravenous infusion in metastatic melanoma

Melanoma Res. 2004 Feb;14(1):63-6. doi: 10.1097/00008390-200402000-00010.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Angiogenesis Inhibitors / therapeutic use*
  • Choroid Neoplasms / drug therapy
  • Choroid Neoplasms / pathology
  • Disease Progression
  • Female
  • Humans
  • Injections, Intravenous
  • Liver Neoplasms / drug therapy*
  • Liver Neoplasms / secondary*
  • Male
  • Maximum Tolerated Dose
  • Melanoma / drug therapy*
  • Melanoma / pathology
  • Middle Aged
  • Paclitaxel / therapeutic use*
  • Remission Induction
  • Skin Neoplasms / drug therapy
  • Skin Neoplasms / pathology
  • Survival Rate
  • Treatment Outcome

Substances

  • Angiogenesis Inhibitors
  • Paclitaxel