BrUOG-EG-203 Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
howard safran, Brown University
ClinicalTrials.gov Identifier:
NCT00439608
First received: February 22, 2007
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Drug: Cetuximab,Paclitaxel, Carboplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BrUOG-EG-203 Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer BMS#CA225091

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Reponse Rate at Time of Surgery by Tissue [ Time Frame: within 30 days of last treatment ] [ Designated as safety issue: No ]
    pathologic complete response rate at surgery


Secondary Outcome Measures:
  • Measure of Safety and Tolerability According to CTC Version 3.0 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: October 2004
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
etuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.
Drug: Cetuximab,Paclitaxel, Carboplatin
IV treatment for 6 weeks

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 resection) for the treatment regimen being tested. With a total accrual of 28 evaluable patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439608

Locations
United States, Rhode Island
Brown University Oncology Group
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
Bristol-Myers Squibb
Investigators
Principal Investigator: Howard Safran, MD Brown University Oncology Research Group
  More Information

No publications provided

Responsible Party: howard safran, Principle Investigator, Brown University
ClinicalTrials.gov Identifier: NCT00439608     History of Changes
Other Study ID Numbers: BrUOG-EG-203, BMS#CA225091
Study First Received: February 22, 2007
Results First Received: May 9, 2013
Last Updated: July 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
esophageal cancer
gastroesophageal cancer
gastric cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Cetuximab
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 20, 2014