Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2011 Apr;22(4):787-793.
doi: 10.1093/annonc/mdq438. Epub 2010 Sep 20.

Phase 3 study of docosahexaenoic acid-paclitaxel versus dacarbazine in patients with metastatic malignant melanoma

A Y Bedikian  1 , R C DeConti  2 , R Conry  3 , S Agarwala  4 , N Papadopoulos  5 , K B Kim  5 , M Ernstoff  6
Affiliations
Clinical Trial

Phase 3 study of docosahexaenoic acid-paclitaxel versus dacarbazine in patients with metastatic malignant melanoma

A Y Bedikian et al. Ann Oncol. 2011 Apr.

Abstract

Background: Docosahexaenoic acid-paclitaxel (DHA-paclitaxel, Taxoprexin(®)) is made by covalently conjugating the essential fatty acid DHA to the paclitaxel molecule. Preclinical studies of DHA-paclitaxel have demonstrated increased activity relative to paclitaxel and the potential for an improved therapeutic ratio. In the present study, the efficacy and toxicity profiles of DHA-paclitaxel were compared with those of dacarbazine.

Methods: In this study, 393 chemonaive patients with metastatic melanoma were randomly assigned to receive either DHA-paclitaxel at a starting dose of 900 mg/m(2) IV on day 1 every 3 weeks or dacarbazine at a starting dose of 1000 mg/m(2) IV on day 1 every 3 weeks. The primary end point of the study was the comparison of overall survival (OS).

Results: No significant difference in OS was noted between patients in the DHA-paclitaxel and dacarbazine arms. Similarly, there were no significant differences in response rate, duration of response, time to progression, and time to treatment failure between the two drugs. Safety results of the two drugs were as predicted from prior studies. Myelosuppression was more common with DHA-paclitaxel.

Conclusions: DHA-paclitaxel was not superior to dacarbazine. We conclude that further studies with the drug on an every 3-week schedule in melanoma are not warranted.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Kaplan–Meier plot of overall survival time for the intent-to treat population (n = 393) of metastatic melanoma patients receiving DHA–paclitaxel or dacarbazine. CI, confidence interval.
Figure 2.
Figure 2.
Time to disease progression in the intent-to-treat population (n = 393) of metastatic melanoma patients receiving DHA–paclitaxel or dacarbazine. CI, confidence interval.
See this image and copyright information in PMC

References

    1. Anderson CM, Buzaid AC, Legha SS. Systemic treatments for advanced cutaneous melanoma. Oncology (Williston Park) 1995;9:1149–1158. - PubMed
    1. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 2000;92:205–216. - PubMed
    1. Avril MF, Aamdal S, Grob JJ, et al. Fotemustine compared with dacarbazine in patients with disseminated malignant melanoma: a phase III study. J Clin Oncol. 2004;22:1118–1125. - PubMed
    1. Bedikian AY, Millward M, Pehamberger H, et al. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol. 2006;24:4738–4745. - PubMed
    1. Atkins MB, Lotze MT, Dutcher JP, et al. High-dose recombinant interleukin-2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999;17:2105–2116. - PubMed

Publication types