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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00439608
Recruitment Status : Completed
First Posted : February 23, 2007
Results First Posted : July 1, 2013
Last Update Posted : April 25, 2019
Bristol-Myers Squibb
Information provided by (Responsible Party):
howard safran, Brown University

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

Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer Drug: Cetuximab,Paclitaxel, Carboplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer BMS#CA225091
Study Start Date : October 2004
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: Treatment
Cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation.
Drug: Cetuximab,Paclitaxel, Carboplatin
IV treatment for 6 weeks

Primary Outcome Measures :
  1. Reponse Rate at Time of Surgery by Tissue [ Time Frame: within 30 days of last treatment ]
    pathologic complete response rate at surgery

Secondary Outcome Measures :
  1. 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. [ Time Frame: baseline, then during treatment, about 5 weeks through 30 days post treatment. ]
    CTCAE version 3: grade 2 and 3 rash. This is reported as it was the most common toxicity.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00439608

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United States, Rhode Island
Brown University Oncology Group
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
Bristol-Myers Squibb
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Principal Investigator: Howard Safran, MD Brown University
  Study Documents (Full-Text)

Documents provided by howard safran, Brown University:

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Responsible Party: howard safran, Principle Investigator, Brown University Identifier: NCT00439608     History of Changes
Obsolete Identifiers: NCT01904435
Other Study ID Numbers: BrUOG-EG-203
BMS#CA225091 ( Other Identifier: BMS )
First Posted: February 23, 2007    Key Record Dates
Results First Posted: July 1, 2013
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by howard safran, Brown University:
esophageal cancer
gastroesophageal cancer
gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological