Combination Chemotherapy and Radiation Therapy in Treating Patients With Cancer of the Esophagus
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|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|
|Actual Primary Completion Date :||October 2000|
|Actual Study Completion Date :||October 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|