Preoperative Therapy With Oxaliplatin/Docetaxel/Capecitabine and Radiation in Resectable Esophagus Cancer
NCT ID: NCT00193128
Last Updated: 2021-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
59 participants
INTERVENTIONAL
2004-04-30
2009-01-31
Brief Summary
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Detailed Description
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Oxaliplatin + Docetaxel + Capecitabine + Radiation therapy
If the three-drug chemotherapy regimen, with radiation therapy, is tolerable, this regimen will be taken forward into the phase II portion of the trial. If the three-drug regimen is too toxic, the phase II portion will proceed with the two-drug regimen Oxaliplatin + Docetaxel + Radiation therapy
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort 1
Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.
Oxaliplatin
40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
Docetaxel
20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
Radiation therapy
In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Cohort 2
Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved.
Oxaliplatin
40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
Docetaxel
20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
Capecitabine
In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.
Radiation therapy
In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Interventions
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Oxaliplatin
40 mg/m2 IV over 2 hours on days 1, 8, 15, 22, and 29 in both treatment cohorts
Docetaxel
20 mg/m2 IV over 30 minutes was administered on days 1, 8, 15, 22, and 29 in both cohorts
Capecitabine
In Cohort 2, capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35.
Radiation therapy
In both cohorts, radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Adenocarcinoma or squamous cell carcinoma of the esophagus or G/E junction.
* Must be surgical candidates
* No previous treatment for esophageal cancer
* Must have measurable or evaluable disease
* Able to perform activities of daily living with minimal to no assistance
* Adequate bone marrow, liver and kidney function
* Provide written informed consent
Exclusion Criteria
* Tumor location in the proximal esophagus
* Metastatic disease or locally advanced cancer
* Moderate to severe peripheral neuropathy
* Serious pre-existing medical illnesses
* Significant heart disease
* Treated for an invasive cancer within the previous 5 years
* Women who are pregnant or breast-feeding
* Age \< 18 years
18 Years
ALL
No
Sponsors
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Sanofi-Synthelabo
INDUSTRY
Aventis Pharmaceuticals
INDUSTRY
SCRI Development Innovations, LLC
OTHER
Responsible Party
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Principal Investigators
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David R. Spigel, MD
Role: PRINCIPAL_INVESTIGATOR
SCRI Development Innovations, LLC
Locations
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Tower Oncology
Beverly Hills, California, United States
Integrated Community Oncology Network
Jacksonville, Florida, United States
Atlanta Cancer Care
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Wellstar Cancer Research
Marietta, Georgia, United States
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States
Tennessee Oncology
Nashville, Tennessee, United States
Countries
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References
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Spigel DR, Greco FA, Meluch AA, Lane CM, Farley C, Gray JR, Clark BL, Burris HA 3rd, Hainsworth JD. Phase I/II trial of preoperative oxaliplatin, docetaxel, and capecitabine with concurrent radiation therapy in localized carcinoma of the esophagus or gastroesophageal junction. J Clin Oncol. 2010 May 1;28(13):2213-9. doi: 10.1200/JCO.2009.24.8773. Epub 2010 Mar 29.
Related Links
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Published article in the Journal of Clinical Oncology
Other Identifiers
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SCRI GI 57
Identifier Type: -
Identifier Source: org_study_id