Summary: Metastatic adenocarcinoma of the colon or rectum

A randomized, double-blind, placebo-controlled, phase III study in patients with metastatic adenocarcinoma of the colon or rectum who are receiving first-line chemotherapy and an investigational drug or placebo.

This study is being conducted to compare the progression free survival in patients being treated with combination chemotherapy plus an investigational drug versus combination chemotherapy plus placebo.

In order to participate in this trial, patients must be 18 years of age or older. Patients must have a confirmed diagnosis of adenocarcinoma of the colon or rectum with metastatic disease.

Key Eligibility Criteria:

Key Inclusion Criteria:

• Patients presenting for first-line chemotherapy with metastatic adenocarcinoma of the colon or rectum
• Histologically or cytologically documented adenocarcinoma metastatic colorectal cancer unless the patient has a history of colorectal cancer treated by surgical resection and who develop radiological or clinical evidence of metastatic cancer and it is < 5 years between surgery and appearance of metastatic cancer
• Age > or = 18 years old

Key Exclusion Criteria:

• History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis)
• Patients with a history of another primary malignancy < or = 5 years, with the exception of inactive basal or squamous cell carcinoma of the skin
• Prior chemotherapy for metastatic colorectal cancer
• Prior full field radiotherapy < or = 4 weeks or limited field radiotherapy < or = 2 weeks prior to randomization. Patients must have recovered from all therapy-related toxicities. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of disease
• Major surgery (i.e., laparotomy) < or = 4 weeks prior to randomization. Minor surgery < or = 2 weeks prior to randomization.
• Any of the following concurrent severe and/or uncontrolled medical conditions including:
  • Uncontrolled high blood pressure, history of labile hypertension, unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction < or = 6 months prior to randomization, serious uncontrolled cardiac arrhythmia
  • Uncontrolled diabetes
• Active or uncontrolled infection (eg. Patients with confirmed diagnosis of human immunodeficiency virus (HIV) infection are excluded at the investigator’s discretion)

 

Contact: Amy Halloran, RN, BSN Southwest Regional Cancer Center 711 West 38th Street, Suite B-1 Austin, TX 78705 Telephone: 512-421-4142 Fax: 512-419-0924 Email: ahalloran@swrcc.com   Profile Page: Southwest Regional Cancer Center, Austin, TX

Provided by MapQuest

If you would like to learn more about participating in this study, please send an e-mail message using the form below. 

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