A PHASE I TRIAL OF COMBINED MODALITY THERAPY FOR LOCALIZED ESOPHAGEAL CANCER: CISPLATIN-PACLITAXEL FOLLOWED BY RADIATION THERAPY WITH CONCURRENT CISPLATIN AND ESCALATING DOSES OF PACLITAXEL
OBJECTIVES: I. Estimate the maximum tolerated dose and recommend a phase II dose for
paclitaxel (TAX) when administered as a 96-hour intravenous infusion with a weekly fixed
dose of intravenous cisplatin (CDDP) during concurrent radiotherapy for patients with
localized esophageal cancer. II. Estimate the response rate of patients treated with 2
courses of TAX/CDDP induction chemotherapy and the complete response rate of patients
treated with TAX/CDDP and concurrent radiotherapy. III. Describe the toxic effects of
TAX/CDDP prior to and during radiotherapy. IV. Describe the pharmacokinetics of TAX as a
continuous infusion (CI) over 96 hours. V. Evaluate, by flow cytometry, the ability of CI
TAX to block esophageal cancer cells in the G2-M phase of the cell cycle.
OUTLINE: After the MTD of TAX is reached on Part A, new patients are entered on Part B. The
following acronyms are used: CDDP Cisplatin, NSC-119875 EBRT External-beam radiotherapy TAX
Paclitaxel (Bristol-Myers), NSC-125973 PART A: Radiotherapy plus 2-Drug Combination
Chemotherapy. EBRT using megavoltage equipment (>/= 10 MV recommended; electron boost
allowed for subclavicular fossae); plus TAX/CDDP. PART B: 2-Drug Combination Induction
Chemotherapy followed by Radiotherapy plus 2-Drug Combination Chemotherapy. TAX/CDDP;
followed by EBRT as in Part A; plus TAX/CDDP.
PROJECTED ACCRUAL: At least 3 patients/dose will be entered on Part A (up to 24 patients)
and 3-6 patients on Part B.
Primary Purpose: Treatment
David Paul Kelsen, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
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