KPStudySearch

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