title: A phase II, open label, monotherapy study of liposomal doxorubicin in patients with metastatic malignant melanoma.
abstract: OBJECTIVE
  This phase II study explored the efficacy and tolerability of pegylated liposomal doxorubicin (PLD) given on a 2 week schedule in patients with advanced malignant melanoma previously untreated by chemotherapy.
  
  
  METHODS
  Patients with inoperable, advanced melanoma were treated with Pegylated liposomal doxorubicin (Caelyx) at a dose of 20 mg/m(2) every 2 weeks. Treatment cycles were repeated every 4 weeks for a maximum of 6 cycles. Patients with responding or stable disease at the end of study treatment, as assessed by using NCI CTG criteria, could continue PLD off-study.
  
  
  RESULTS
  PLD administered as a 2 weekly IV infusion was well tolerated with mild infusion reactions usually associated with the first infusion. Myelosuppression was mild, as was nausea and vomiting. Palmar plantar erythrodysesthesia was also uncommon using this schedule. There were no objective responses seen in the 14 evaluable patients. Enrollment was stopped as per protocol, due to lack of activity.
  
  
  CONCLUSIONS
  PLD was well tolerated using a 2 week schedule but failed to show any activity in chemotherapy naive patients with advanced malignant melanoma.
authors.affiliation: Department of Medicine, Cross Cancer Institute, 11560 University Avenue, Edmonton, Alberta T6G1Z2. michaels@cancerboard.ab.ca
authors.forename: Michael G
authors.initials: MG
authors.lastname: Smylie
authors.forename: Ralph
authors.initials: R
authors.lastname: Wong
authors.forename: Catalin
authors.initials: C
authors.lastname: Mihalcioiu
authors.forename: Chris
authors.initials: C
authors.lastname: Lee
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Pouliot
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D004337:Drug Carriers; D023381:Endpoint Determination; D005079:Excipients; D005260:Female; D006801:Humans; D008081:Liposomes; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011092:Polyethylene Glycols; D016019:Survival Analysis
chemical_list: D000903:Antibiotics, Antineoplastic; D004337:Drug Carriers; D005079:Excipients; D008081:Liposomes; D011092:Polyethylene Glycols; D004317:Doxorubicin