Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer
Completed · Phase 2
Conditions studied: Esophageal Cancer, Gastric Cancer
In brief
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
Key facts
- Study ID
- NCT00439608
- Run by
- Brown University
- People needed
- 60
- Starts
- 2004-10-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2020-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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).
Where it is running
- Brown University Oncology Group — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
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