Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer

Study Overview
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Brief Summary
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Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer

Detailed Description
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The primary objective of this phase II trial is to estimate the rate of complete pathologic response as determined by surgical resection or post treatment endoscopy (for patients not undergoing resection) for the treatment regimen being tested. With a total accrual of 28 evaluable patients.

Official Title
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Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer BMS#CA225091

Conditions
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Esophageal Cancer, Gastric Cancer

Intervention / Treatment
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* Drug: Cetuximab,Paclitaxel, Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, gastroesophageal junction, or stomach. Patients may have mediastinal, celiac adenopathy, peri-portal and regional gastric lymphadenopathy. There must be no evidence of distant organ metastases. No prior radiation for gastric or esophageal cancer. Patients must be > 18 years of age, and nonpregnant Patients must have an ANC > 1,500/ul, platelets > 100,000/ul, creatinine < 2 x upper limit normal (ULN) and bilirubin < 1.5 x ULN, and AST < 3 x ULN. ECOG performance status 0-2. Patients must not have significant infection or other coexistent medical condition that would preclude protocol therapy. Female patients, must either be not of child bearing potential or have a negative pregnancy test within 7 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible. All patients must sign informed consent Exclusion Criteria: Any of the following criteria will make the patient ineligible to participate in this study: Acute hepatitis or AIDS. Active or uncontrolled infection. Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction. Prior therapy which specifically and directly targets the EGFR pathway. Prior severe infusion reaction to a monoclonal antibody. Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation. | Drug: Cetuximab,Paclitaxel, Carboplatin<br>* IV treatment for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reponse Rate at Time of Surgery by Tissue | pathologic complete response rate at surgery | within 30 days of last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Grade 2 and/or 3 Rash in Patients With Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus, Gastroesophageal Junction, or Stomach. | CTCAE version 3: grade 2 and 3 rash. This is reported as it was the most common toxicity. | baseline, then during treatment, about 5 weeks through 30 days post treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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esophageal cancer, gastroesophageal cancer, gastric cancer