Esophageal Cancer Clinical Trial

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

Summary

Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer

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Full Description

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.

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Eligibility Criteria

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).

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT00439608

Recruitment Status:

Completed

Sponsor:

Brown University

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There is 1 Location for this study

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Brown University Oncology Group
Providence Rhode Island, 02912, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT00439608

Recruitment Status:

Completed

Sponsor:


Brown University

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