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Therapeutic Areas: Oncology | Otolaryngology (Ear, Nose, Throat) | Pulmonary/Respiratory Diseases | Family Medicine
Disease Category: Esophageal Cancer
Location: United States, IL

Clinical Trial Details

Overview

Research Study Summary

ECOG E2208 Phase II Randomized Study of Paclitaxel With Versus Without Cixutumumab as Second-Line Therapy in Patients With Metastatic Esophageal or Gastroesophageal Junction Cancer

Purpose

WHY IS THIS STUDY BEING DONE?

The purpose of this study is to find out what effects, good and/or bad, cixutumumab (IMC-A12) has on you and your esophagus cancer when combined with a chemotherapy drug, paclitaxel. Cixutumumab is an investigational drug, which means it has not been approved by the FDA for use in this cancer. All patients will receive a chemotherapy drug called paclitaxel as part of this study. Paclitaxel is a chemotherapy drug which has benefitted some patients with esophagus cancer. It is approved to treat several different types of cancer but it has not been approved by the FDA to treat esophagus cancer. Some patients will receive cixutumumab with the paclitaxel.

Patient Inclusion Criteria:

  • Age >18 years of age
  • Histologically, cytologically, or radiologically confirmed metastatic esophageal or gastroesophageal junction meeting 1 of the following criteria:
    1. Squamous cell carcinoma
    2. Adenocarcinoma
    3. Undifferentiated adenocarcinomas and adenosquamous tumors will be considered as adenocarcinomas

  • Patients with adenocarcinoma of the gastroesophageal or esophagogastric (AEG) junction tumors meeting the following:
    1. AEG type I: adenocarcinoma of the distal esophagus that usually arises from an area with specialized intestinal metaplasia of the esophagus (i.e., Barrett esophagus) and may infiltrate the esophagogastric junction from above
    2. AEG type II: true carcinoma of the cardia arising from the cardiac epithelium or short segments with intestinal metaplasia at the esophagogastric junction
    3. Evidence of local recurrence or local residual (post-resection) disease by radiology, endoscopy, histology, or cytology allowed
    4. Measurable disease

  • Must have received and progressed on 1 line of prior systemic therapy for esophageal or esophagogastric cancer meeting ≥ 1 of the following criteria:
    1. May have included one regimen for metastatic disease, or one regimen with radiotherapy for initially locally advanced disease
    2. If patients progress or recur within 6 months of neoadjuvant/adjuvant therapy, this will be considered one line of therapy
    3. For patients progressing or recurring more than 6 months after neoadjuvant/adjuvant therapy, they will need to receive one line of therapy for recurrent disease to be eligible
    4. If patients receive one regimen in which a chemotherapy agent is dropped for toxicity without progression, this treatment will be considered 1 line of therapy
    5. Substitution or addition of a new agent will be considered a second line of therapy

Patient Exclusion Criteria:

  • No AEG type III: subcardial gastric carcinoma that infiltrates the esophagogastric junction and distal esophagus from below

To Learn more
Phase

2

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Facility Type

N/A

Contact

Janeen V. Bazan, RN OCN BSN CCRP, Oncology Research Nurse Program Coordinator
Sherman Health
1425 North Randall Road
Elgin, IL 60123
Phone: 224-783-2907
Fax: 224-783-3071

View Map

Research Center Information: Sherman Health

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 183108

Date Last Changed: July 17, 2013


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