Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Jennifer Chan, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00130689
First received: August 15, 2005
Last updated: December 18, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to determine the response rate of cetuximab in patients with advanced esophageal or gastric cancer.

The secondary purposes are to determine the safety and to evaluate the duration of response in patients treated with cetuximab.


Condition Intervention Phase
Esophageal Cancer
Gastric Cancer
Neoplasm Metastasis
Drug: Cetuximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Cetuximab in Unresectable or Metastatic Esophageal and Gastric Carcinoma

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To assess the response rate of cetuximab in patients with advanced esophageal or gastric cancer that has not responded to 1-2 prior chemotherapy regimens given in the metastatic setting [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the duration of response, progression-free survival and overall survival of patients with advanced or metastatic esophageal or gastric cancer treated with cetuximab [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • to assess the safety of cetuximab [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 38
Study Start Date: July 2005
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cetuximab
Single arm
Drug: Cetuximab
Once weekly until disease progression

Detailed Description:

Cetuximab will be administered to the patient once weekly until disease progression or development of toxicity preclude further treatment. One treatment cycle is considered 4 weeks. While receiving cetuximab, the patients' vitals will be monitored weekly, every 4 weeks (1 cycle), bloodwork and a physical exam will be performed and every 8 weeks (2 cycles), reassessment of the tumor and urine pregnancy test for women patients of childbearing potential will be performed.

All patients will be evaluated by history and physical exam at the end of the study treatment.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00130689

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
North Shore Medical Center Cancer Center
Peabody, Massachusetts, United States
Sponsors and Collaborators
Dana-Farber Cancer Institute
Bristol-Myers Squibb
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Jennifer Ang Chan, MD Dana-Farber Cancer Institute
  More Information

Publications:
Responsible Party: Jennifer Chan, MD, MPH, Overall PI, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00130689     History of Changes
Other Study ID Numbers: 05-113
Study First Received: August 15, 2005
Last Updated: December 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Esophageal Cancer
Gastric Cancer
Metastatic Esophageal Cancer
Metastatic Gastric Cancer
Cetuximab
Metastatic Esophageal and Gastric Cancer

Additional relevant MeSH terms:
Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplastic Processes
Pathologic Processes
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014