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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

February 22, 2007
July 1, 2013
October 2004
April 2010   (final data collection date for primary outcome measure)
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
To determine the pathologic complete response rate
Complete list of historical versions of study NCT00439608 on ClinicalTrials.gov Archive Site
Measure of Safety and Tolerability According to CTC Version 3.0 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
to evaluate toxicities, progression-free and overall survival.
Not Provided
Not Provided
 
BrUOG-EG-203 Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
BrUOG-EG-203 Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer BMS#CA225091

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

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Esophageal Cancer
  • Gastric Cancer
Drug: Cetuximab,Paclitaxel, Carboplatin
IV treatment for 6 weeks
Experimental: Treatment
etuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.
Intervention: Drug: Cetuximab,Paclitaxel, Carboplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2010
April 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00439608
BrUOG-EG-203, BMS#CA225091
Yes
howard safran, Brown University
Brown University
Bristol-Myers Squibb
Principal Investigator: Howard Safran, MD Brown University Oncology Research Group
Brown University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP