Phase 2 open-label study of weekly docosahexaenoic acid-paclitaxel in patients with metastatic uveal melanoma

• Published in: Melanoma research Vol. 20; no. 6; p. 507
• Main Authors: Homsi, Jade, Bedikian, Agop Y, Papadopoulos, Nicholas E, Kim, Kevin B, Hwu, Wen-Jen, Mahoney, Sandy L, Hwu, Patrick
• Format: Journal Article
• Language: English
• Published: England 01.12.2010
• Subjects: Adult; Aged; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Drug Administration Schedule; Female; Humans; Male; Melanoma - drug therapy; Middle Aged; Neoplasm Metastasis; Paclitaxel - adverse effects; Paclitaxel - analogs & derivatives; Paclitaxel - therapeutic use; Survival Rate; Uveal Neoplasms - drug therapy
• ISSN: 1473-5636
• DOI: 10.1097/CMR.0b013e3283403ce9

Docosahexaenoic acid (DHA)-paclitaxel is a taxane with a unique pharmacokinetic profile. We investigated the safety and response rate of DHA-paclitaxel weekly in patients with metastatic uveal melanoma. Chemotherapy-naive and previously treated patients were eligible for this open-label phase II study. DHA-paclitaxel (500 mg/m²/week) was administered by a 1-hour intravenous infusion for five consecutive weeks in a 6-weeks cycle. Response was assessed using the Response Evaluation Criteria in Solid Tumors every 6 weeks. Twenty-two patients were enrolled. The patients' median age was 56 years (range: 33-79 years). Nine patients had a systemic therapy for metastatic disease earlier. The median number of treatment cycles was 1 (range 1-7 cycles). One chemonaive patient with liver metastases had partial response lasting for 5 months. Seven patients (32%) had stable disease with a median duration of 3 months (range: 3-7 months). The median overall survival was 9.8 months. Neutropenia (23%) and musculoskeletal pain (10%) were the most common grade 3 and grade 4 toxicities. As a single-agent therapy, DHA-paclitaxel is safe and well-tolerated in metastatic uveal melanoma patients. Its efficacy in this disease is limited with 32% of patients achieving stable disease. Further evaluation of DHA-paclitaxel in combination with other chemotherapeutic agents and/or targeted agents may improve its antitumor activity.