This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Rosenthal, D. I. Articles by Carbone, D. P. Search for Related Content PubMed PubMed Citation Articles by Rosenthal, D. I. Articles by Carbone, D. P. Social Bookmarking                            What's this?

Phase I Study of Paclitaxel Given by Seven-Week Continuous Infusion Concurrent With Radiation Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

From the University of Pennsylvania Medical Center, Philadelphia; University of Pittsburgh Cancer Institute, Pittsburgh, PA; University of Texas Southwestern Medical Center, Dallas, TX; University of Maryland Greenebaum Cancer Center, Baltimore, MD; and the Vanderbilt Cancer Center, Nashville, TN.

Submitted April 4, 2000; accepted November 8, 2000. Address reprint requests to David I. Rosenthal, MD, Department of Radiation Oncology, University of Pennsylvania Medical Center, 3400 Spruce St, Philadelphia, PA 19104; email: rosenthal{at}xrt.upenn.edu

PURPOSE: Paclitaxel is one of the most active agents for squamous cell carcinoma of the head and neck (SCCHN) and an in vitro radiosensitizer. The dose-response relationship for paclitaxel may depend more on exposure duration than on peak concentration. This National Cancer Institute–sponsored phase I trial was designed to determine the feasibility of combining continuous-infusion (CI) paclitaxel with concurrent radiation therapy (RT).

PATIENTS AND METHODS: Patients with previously untreated stage IVA/B SCCHN were eligible. Primary end points were determination of the maximum-tolerated dose, dose-limiting toxicity, and pharmacokinetics for paclitaxel given by CI (24 hours a day, 7 days a week for 7 weeks) during RT (70 Gy/7 weeks).

RESULTS: Twenty-seven patients were enrolled and assessable for toxicity. Nineteen of the patients who completed 70 Gy were assessable for response. Grade 3 skin and mucosal acute reactions occurred at 10.5 mg/m²/d, but uninterrupted treatment was possible in five of six patients. At 17 mg/m²/d, skin toxicity required a 2-week treatment break for all three patients. The mean paclitaxel serum concentration at dose levels 6.5 mg/m²/d exceeded that reported to achieve in vitro radiosensitization. Initial locoregional control was achieved in 14 (58%) of 24 of patients treated to 70 Gy, and control persisted in nine (38%).

CONCLUSION: CI paclitaxel with concurrent RT is a feasible and tolerable regimen for patients with advanced SCCHN and good performance status. Preliminary response and survival data are encouraging and suggest that further study is indicated. The recommended phase II dose of paclitaxel by CI is 10.5 mg/m²/d with RT for SCCHN.

Presented in part at the Thirty-Fifth Annual Meeting of the American Society of Clinical Oncology, May 15-18, 1999, Atlanta, GA.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				Y. Hasegawa, S. Takanashi, K. Okudera, M. Aoki, K. Basaki, H. Kondo, T. Takahata, N. Yasui-Furukori, T. Tateishi, Y. Abe, et al. Weekly Paclitaxel and Nedaplatin With Concurrent Radiotherapy for Locally Advanced Non-small-cell Lung Cancer: a Phase I/II Study Jpn. J. Clin. Oncol., November 1, 2004; 34(11): 647 - 653. [Abstract] [Full Text] [PDF]

				B. Jeremic, B. Milicic, A. Dagovic, Z. Vaskovic, and L. Tadic Radiation Therapy With or Without Concurrent Low-Dose Daily Chemotherapy in Locally Advanced, Nonmetastatic Squamous Cell Carcinoma of the Head and Neck J. Clin. Oncol., September 1, 2004; 22(17): 3540 - 3548. [Abstract] [Full Text] [PDF]

				P. W. T. Pisters, R. A. Wolff, N. A. Janjan, K. R. Cleary, C. Charnsangavej, C. N. Crane, R. Lenzi, J. Nicolas Vauthey, J. E. Lee, J. L. Abbruzzese, et al. Preoperative Paclitaxel and Concurrent Rapid-Fractionation Radiation for Resectable Pancreatic Adenocarcinoma: Toxicities, Histologic Response Rates, and Event-Free Outcome J. Clin. Oncol., May 15, 2002; 20(10): 2537 - 2544. [Abstract] [Full Text] [PDF]