A phase II trial of weekly 1-hour paclitaxel in stage IV melanoma

Abstract

7565 Background: Stage IV melanoma patients have a median survival of 8 months. Several agents have limited activity with response rates of approximately 20%. Since tumor response to paclitaxel may be schedule dependent, the effect of weekly paclitaxel in patients with metastatic melanoma was studied. Methods: Stage IV melanoma that was surgically unresectable, ECOG performance status (PS) of 0 or 1, measurable disease, age greater than 18, adequate end organ function and hematologic parameters were treated with Paclitaxel at 80mg/m2 intravenously weekly times 6 weeks followed by a 1-week break. Standard paclitaxel premedications were given. Toxicity assessments were done every 2 weeks and tumor measurements were done every 7 weeks. Treatment was given until progression or toxicity. Results: 21 patients (pts) enrolled between 8/99 to 8/04. Pt Characteristics: median age 55, ten males, ECOG PS 0 in 6, and 1 in 15. Sites of measurable disease were lung (9), skin (3), lymph nodes (not regional) (5), liver (3), kidney (3), spleen (1). All but six had prior chemotherapy, biochemotherapy, immune treatment or combinations of these. Number of prior therapies were 1 in 4 pts, 2 in 4 pts, 3 in 5 pts, and 4 in 2 pts. There were a total of 36 cycles administered (median number of 1.8 cycles). There were 18/21 evaluable pts. CR 2(11%), PR 2 (11%), ORR (22%), SD 7(39%), PD (39%). All of the patients with SD, or PR eventually progressed and came off therapy except for one patient with SD who stopped after 4 cycles. The survival at 12 months is 0.299 (CI .080-.517). The median time to disease progression is available for 14 of 17 patients (1 is still on study) and was 13 weeks. No grade (gd) 4 toxicities and only four pts had gd 3 neutropenia, 2 had gd 3 anemia, and one pt had gd 3 ototoxicity. Conclusions: Weekly paclitaxel at 80mg/m2/week X 6 weeks out of 7 is a well tolerated treatment for melanoma that has minimal activity in this heavily pretreated population. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb, Eli Lilly Bristol-Myers Squibb