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Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Phase III Trial Evaluating The Addition Of Trastuzumab To Trimodality Treatment Of Her2-Overexpressing Esophageal Adenocarcinoma
 
Region Sponsors
California - Northern
National Cancer Institute (NCI)
 
Acronym KP IRB No.
CN-11SSeaw-01-B
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Adenocarcinoma of the Esophagus; Adenocarcinoma of the Gastroesophageal Junction; Stage IB Esophageal Cancer; Stage IIA Esophageal Cancer; Stage IIB Esophageal Cancer; Stage IIIA Esophageal Cancer; Stage IIIB Esophageal Cancer
 
Purpose
This randomized phase III trial studies how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving radiation therapy and combination chemotherapy together with or without trastuzumab is more effective in treating esophageal cancer.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Zubrod performance status 0-2
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm³
  • Platelets >=100,000 cells/mm³
  • Hemoglobin >= 8.0 g/dL (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dL is acceptable)
  • Creatinine =< 2 times upper limit of normal
  • Bilirubin =< 1.5 times upper limit of normal
  • Aspartate aminotransferase (AST) =< 3.0 times upper limit of normal
 
Exclusion Criteria
  • Patients with cervical esophageal carcinoma
  • Patients with T1N0 disease, T4 disease, and proximal esophageal cancers (15-24 cm) Prior systemic chemotherapy for esophageal cancer (note that prior chemotherapy for a different cancer is allowable)
  • Prior radiation therapy for esophageal cancer or prior chest radiotherapy
  • Prior anthracycline or taxane
  • Evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi
  • Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 2 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are permissible)
  • Medical contraindications to esophagectomy

 
Keywords and/or Specific Medical Conditions
  • Adenocarcinoma
  • Mitosis Modulators
  • Antimitotic Agents
  • Molecular Mechanisms of Pharmacological Action
  • Antineoplastic Agents
  • Neoplasms
  • Antineoplastic Agents, Phytogenic
  • Neoplasms by Histologic Type
  • Carboplatin
  • Neoplasms by Site
  • Carcinoma
  • Neoplasms, Glandular and Epithelial
  • Digestive System Diseases
  • Paclitaxel
  • Digestive System Neoplasms
  • Pharmacologic Actions
  • Esophageal Diseases
  • Therapeutic Uses
  • Esophageal Neoplasms
  • Trastuzumab
  • Gastrointestinal Diseases
  • Tubulin Modulators
  • Gastrointestinal Neoplasms
  • Gastroenterology
  • Head and Neck Neoplasms
  • Oncology (Adult)
 
KP Clinical Facility
  • Central Valley-Modesto
  • Central Valley-Stockton
  • Diablo Medical Center-Walnut Creek
  • Fremont Medical Center
  • Hayward Medical Center
  • Oakland Medical Center
  • Redwood City Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Rosa Medical Center
  • Santa Teresa Medical Center-San Jose
  • South Sacramento Medical Center
  • South San Francisco Medical Center
  • Vallejo Medical Center
  • Vallejo Medical Center-Vacaville
 
Clinical Area
  • Gastroenterology
  • Oncology (Adult)


Principal Investigator:
Samantha Seaward, MD
Contact Information:
- Marion Cruz, RN
-(707) 651-2799
-Vallejo Medical Center
- Cynthia Walker, RN
-(925) 295-5924
-Diablo Medical Center-Walnut Creek
- Shanae Moffett, RN
-(510) 784-4533
-Fremont Medical Center


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