Neoplasms

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Carcinoma

Neoplasm Metastasis

Stomach Neoplasms

Esophageal Neoplasms

Neoplastic Processes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Stomach Cancer

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Antineoplastic Agents, Immunological

Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.

Jennifer A. Chan, MD

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 expression in a significant proportion of both esophageal and gastric carcinomas. Inactivation of EGFR through use of a monoclonal antibody in preclinical models has resulted in inhibition of tumor growth. Agents designed to block the EGFR pathway have demonstrated disease control among previously treated patients with metastatic esophageal and gastric cancer. The proposed mechanism of action for cetuximab is its ability to effectively disrupt EGFR-mediated signal transduction pathways that ultimately leads to halting cell cycle progression, induces apoptosis, and also inhibits processes important for tumor growth, such as cell invasion and angiogenesis.

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 metastatic setting.

Secondary

* To evaluate the duration of response, progression-free survival and overall survival.
* To assess the safety of cetuximab.

Exploratory

- To assess whether levels of EGFR expression and/or EGFR mutation status correlates with response and toxicity of cetuximab.

STATISTICAL DESIGN:

This study used a two-stage design to evaluate efficacy of cetuximab based on overall response (OR) defined as complete response (CR) or partial response (PR). The null and alternative OR rate were 5% and 15%. If one or more patients enrolled in the stage one cohort (n=20 patients) achieved PR or better than accrual would proceed to stage two (n=16 patients). There was 36% probability of stopping the trial at stage one if the true OR rate was 5%. The probability that the regimen would be considered promising if the true OR rate was 5% was 10% and 80% if the true OR rate was 15%.

Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer

A Phase II Trial of Cetuximab in Unresectable or Metastatic Esophageal and Gastric Carcinoma

Overall response (OR) rate was defined as achieving partial response (PR) or complete response (CR) based on RECIST 1.0 criteria on treatment. Per RECIST 1.0 for target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. To be assigned a status of CR or PR, changes in tumor measurements must be confirmed by repeat assessments performed no fewer than 4 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

Bristol-Myers Squibb

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute

Overall PI

Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. Other AEs were defined as events with treatment-attribution of possible, probable or definite and grades 1 or 2 per CTCAEv3.

Age, Customized

Sex: Female, Male

United States

Region of Enrollment

Esophagael

GE Junction

Gastric

Primary Tumor

The analysis dataset is comprised of eligible and treated patients.

Jennifer Ang Chan, MD, MPH

Responses were determined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Overall Response Rate

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer	NCT00130689	Esophageal Canc... Gastric Cancer Neoplasm Metast...	Cetuximab	18 Years -	Dana-Farber Cancer Institute
Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer	NCT00130689	Esophageal Canc... Gastric Cancer Neoplasm Metast...	Cetuximab	18 Years -	Dana-Farber Cancer Institute

Spots Global Cancer Trial Database for metastatic esophageal and gastric cancer