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Phase 2 N=60 Treatment

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

Esophageal Cancer · Gastric Cancer

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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