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Phase 2 open-label study of weekly docosahexaenoic acid-paclitaxel in cutaneous and mucosal metastatic melanoma patients
Melanoma Research, 07/24/09

Homsi J et al. - In a trial to investigate the response rate and safety of weekly docosahexaenoic acid (DHA)-paclitaxel in metastatic melanoma pts, it appears that as single-agent therapy, DHA-paclitaxel was well tolerated in metastatic melanoma pts. Its efficacy as a first-line therapy for metastatic melanoma does not exceed that seen with other single-agent chemotherapies such as dacarbazine.

• Chemotherapy-naive pts with metastatic nonchoroidal melanoma were enrolled using the 2-stage Fleming design.
• At least 1 response was needed in the first stage to proceed to the second stage.
• DHA-paclitaxel (500 mg/m2/wk by 1-h intravenous infusion) was administered for 5 wks every 6-wk cycle until disease progression, intolerable toxicity, or treatment refusal.
• Response and toxicity were assessed every 6 wks and wkly, respectively.

• 30 pts were enrolled; median age was 67 yrs.
• Median number of treatment cycles was 2.
• 3 pts (10%) had partial responses; 1 lasted 4 mos, and 2 lasted 5.6 mos.
• 15 pts (50%) had stable disease with a median duration of 2.8 mos.
• Median survival was 14.8 mos.
• Neutropenia (10%) and musculoskeletal pain (10%) were the most common grade 3 and 4 toxicities, and fatigue (73%), skin rash (70%), and diarrhea (60%) were the most common side effects.

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