Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
|ClinicalTrials.gov Identifier: NCT00002711|
Recruitment Status : Completed
First Posted : August 24, 2004
Last Update Posted : July 3, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients with cancer of the esophagus.
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: chemotherapy Drug: cisplatin Drug: paclitaxel Radiation: low-LET electron therapy Radiation: low-LET photon therapy||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Official Title:||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|
|Study Start Date :||October 1995|
|Primary Completion Date :||October 2000|
|Study Completion Date :||October 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002711
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David Paul Kelsen, MD||Memorial Sloan Kettering Cancer Center|