Status:
COMPLETED
Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer
Lead Sponsor:
Brown University
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Esophageal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
Detailed 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 resect...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00439608
Start Date
October 1 2004
End Date
April 1 2010
Last Update
February 17 2020
Active Locations (1)
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1
Brown University Oncology Group
Providence, Rhode Island, United States, 02912