A phase II, open label, monotherapy study of liposomal doxorubicin in patients with metastatic malignant melanoma
- 7 September 2006
- journal article
- Published by Springer Science and Business Media LLC in Investigational New Drugs
- Vol. 25 (2), 155-159
- https://doi.org/10.1007/s10637-006-9002-y
Abstract
Purpose: 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. Patients and methods: Patients with inoperable, advanced melanoma were treated with Pegylated liposomal doxorubicin (Caelyx®) at a dose of 20 mg/m2 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. Conclusion: PLD was well tolerated using a 2 week schedule but failed to show any activity in chemotherapy naive patients with advanced malignant melanoma.Keywords
This publication has 11 references indexed in Scilit:
- Phase II study of pegylated liposomal doxorubicin in patients with metastatic malignant melanoma failing standard chemotherapy treatmentMelanoma Research, 2003
- Sequential Biochemotherapy Versus Chemotherapy for Metastatic Melanoma: Results From a Phase III Randomized TrialJournal of Clinical Oncology, 2002
- Phase III Multicenter Randomized Trial of the Dartmouth Regimen Versus Dacarbazine in Patients With Metastatic MelanomaJournal of Clinical Oncology, 1999
- Phase II trial of doxil for patients with metastatic melanoma refractory to frontline therapy.Oncology Reports, 1999
- Prospective Randomized Trial of the Treatment of Patients With Metastatic Melanoma Using Chemotherapy With Cisplatin, Dacarbazine, and Tamoxifen Alone or in Combination With Interleukin-2 and Interferon Alfa-2bJournal of Clinical Oncology, 1999
- Combination of Chemotherapy With Interleukin-2 and Interferon Alfa for the Treatment of Metastatic MelanomaJournal of Clinical Oncology, 1999
- Development and results of biochemotherapy in metastatic melanoma: the University of Texas M.D. Anderson Cancer Center experience.1997
- Systemic chemotherapy for the treatment of metastatic melanoma.1996
- Sequential chemoimmunotherapy with cisplatin, interleukin-2, and interferon alfa-2a for metastatic melanoma.Journal of Clinical Oncology, 1993
- Phase II study of adriamycin (NSC-123127) in patients with metastatic melanoma.1975