Trial Information

Phase I Study of Concomitant Chemoradiotherapy With Vinorelbine and Paclitaxel in Patients With Advanced Pelvic Malignancies

OBJECTIVES: I. Assess the toxic effects of vinorelbine given on a weekly schedule combined
with standard whole pelvic radiation therapy. II. Determine the Maximum Tolerated Dose (MTD)
of vinorelbine given on a weekly schedule combined with standard whole pelvic radiation
therapy. III. Access the toxic effects of paclitaxel given weekly in combination with the
regimen determined to be the MTD of vinorelbine. IV. Determine the MTD of paclitaxel given
weekly in combination with the regimen determined to be the MTD of vinorelbine.

OUTLINE: Part I: Vinorelbine IV bolus is administered over 8-10 minutes on day 1 prior to
radiation therapy. Whole pelvic radiation treatment is given on days 1-5 followed by 2 days
of rest. The treatment volume encompasses all suspected pelvic disease with a minimum of 1
cm margin. Cycles repeat weekly. Dose of vinorelbine is escalated in cohorts of at least 3
patients until maximum tolerated dose (MTD) is determined. Part II: Paclitaxel is infused
over 1 hour immediately following vinorelbine at the MTD, as determined in part I. Dose of
paclitaxel is escalated in cohorts of at least 3 patients until the MTD is determined. At
least 6 patients are treated at the MTD for both parts I and II of the study. Patients are
followed for late and chronic toxicities.

PROJECTED ACCRUAL: Projected accrual is 12 patients per year for approximately 3 years.