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BrUOG-EG-203 Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer BMS#CA225091


Phase 2
18 Years
N/A
Not Enrolling
Both
Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

BrUOG-EG-203 Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer BMS#CA225091


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.


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pathologic complete response rate at surgery

Outcome Time Frame:

within 30 days of last treatment

Safety Issue:

No

Principal Investigator

Howard Safran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brown University

Authority:

United States: Institutional Review Board

Study ID:

BrUOG-EG-203

NCT ID:

NCT00439608

Start Date:

October 2004

Completion Date:

April 2010

Related Keywords:

  • Esophageal Cancer
  • Gastric Cancer
  • esophageal cancer
  • gastroesophageal cancer
  • gastric cancer
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

Name

Location

Brown University Oncology GroupProvidence, Rhode Island  02912