Status:
COMPLETED
Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Bristol-Myers Squibb
Massachusetts General Hospital
Conditions:
Esophageal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Purpose: There remains a great need for novel therapeutic agents and treatment strategies for advanced esophagogastric cancer. Preclinical and clinical studies have demonstrated increased EGFR express...
Detailed Description
OBJECTIVES: Primary - To assess the response rate of single-agent cetuximab in patients with advanced esophageal or gastric cancer who have failed 1-2 prior chemotherapy regimens given in the metasta...
Eligibility Criteria
Inclusion
- Histologically confirmed, unresectable or metastatic stage IV esophageal or gastric adenocarcinoma. Tumors with squamous cell differentiation, including those with a mixture of squamous and adenomatous differentiation, are excluded.
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan or greater than or equal to 2 cm by other radiographic technique. Disease in an irradiated field as only site of measurable disease is acceptable if there has been a clear progression of the lesion.
- Patients must have at least one paraffin block or twenty unstained slides available for analysis of epidermal growth factor receptor (EGFR) status.
- Treatment with 1-2 prior chemotherapy regimens given in the metastatic setting for unresectable or metastatic esophageal or gastric carcinoma.
- ECOG performance status 0-2.
- Life expectancy greater or equal to 12 weeks.
- Age 18 years or older.
- Ability to sign an informed consent document.
- Neutrophils greater than or equal to 1,000/mm3.
- Platelets greater than or equal to 75,000/mm3.
- Serum bilirubin less than or equal to 2.0 mg/dl.
- Serum creatinine less than or equal to 1.5 mg/dl.
- Aspartate aminotransferase (AST or SGOT) less than or equal to 2.5 x upper institutional normal limit.
Exclusion
- Pregnant or lactating women. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of initiation of therapy. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while in this study.
- Subjects should have no other active malignancy other than non-melanoma skin cancer or in-situ cervical carcinoma. A resected cancer (other than in-situ carcinoma) must have demonstrated no evidence of recurrence for at least 3 years.
- Subjects should not have a significant history of cardiac disease, i.e., uncontrolled hypertension; unstable angina; congestive heart failure; myocardial infarction less than 6 months prior to registration; or serious uncontrolled cardiac arrhythmia.
- Subjects must not have received prior cetuximab or other therapy that specifically and directly targets the EGFR pathway. Prior therapy with bevacizumab is permissible.
- Subjects must not have experienced prior severe infusion reaction to a monoclonal antibody.
- Subjects must not have received any chemotherapy regimen or radiation therapy within 28 days prior to study entry.
- Patients must have completed any major surgery 4 weeks or any minor surgery 2 weeks prior to the first infusion of cetuximab. Patients must have fully recovered from the procedure.
- No concurrent use of chemotherapy, radiation, or other investigational agents is allowed while participating in this study.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00130689
Start Date
July 1 2005
End Date
September 1 2010
Last Update
May 14 2015
Active Locations (4)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
4
North Shore Medical Center Cancer Center
Peabody, Massachusetts, United States