Phase 2
N=60
Cetuximab, Paclitaxel, Carboplatin & Radiation for Esoph, Gastroesoph & Gastric Cancer
Esophageal Cancer · Gastric Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00439608 ↗Enrolled (actual)
60
Serious AEs
11.7%
Results posted
Jul 2013
Primary outcome: Primary: Reponse Rate at Time of Surgery by Tissue — 40 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cetuximab,Paclitaxel, Carboplatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brown University
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reponse Rate at Time of Surgery by Tissue |
40 | — |
| SECONDARY 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. |
37 | — |
Summary
Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
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).
Data sourced from ClinicalTrials.gov (NCT00439608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.