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Colorectal Cancer

Octreotide and Interferon Alfa-2b or Bevacizumab for Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor (SWOG 0518)
Phase III Prospective Randomized Comparison of Depot Octreotide (Sandostatin) plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (Avastin) (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
Status Conditions Phase Study ID
Recruiting Neuroendocrine Carcinoma
Gastrointestinal Cancer		 Phase III SWOG 0518
NCT00569127
Summary

RATIONALE: Octreotide and interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving octreotide together with interferon alfa-2b is more effective than giving octreotide together with bevacizumab in treating patients with neuroendocrine tumor.

PURPOSE: This randomized phase III trial is studying giving octreotide together with interferon alfa-2b to see how well it works compared with giving octreotide together with bevacizumab in treating patients with metastatic or locally advanced, high-risk neuroendocrine tumor.


Investigator
Fred Appelbaum, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

Inclusion criteria:

  • Diagnosis of unresectable metastatic or locally advanced, low- or intermediate-grade neuroendocrine carcinoma, including the following subtypes:

    • Carcinoid tumor, low-grade or well differentiated neuroendocrine carcinoma
    • Atypical carcinoid tumor, intermediate-grade or moderately differentiated neuroendocrine carcinoma

  • High-risk disease as defined by at least one of the following:

    • Progressive disease
    • Refractory carcinoid syndrome while receiving octreotide acetate (i.e., defined by > 2 flushing episodes/day or > 4 bowel movements/day)
    • Atypical histology and more than 6 lesions

    • Metastatic colorectal carcinoid tumor

      • Patients with metastatic cecal or appendiceal carcinoid tumor are not eligible unless they fit other mentioned high-risk features
    • Metastatic gastric carcinoid tumor
  • Measurable disease
  • Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid tumor, or goblet cell carcinoid tumor are not eligible
Exclusions (conditions that would prevent participation in this study)
  • Osseous metastasis as only site of disease
  • Medullary thyroid carcinoma or islet cell carcinoma
  • History of primary brain tumor or metastatic cancer to the brain
Last Updated
June 15, 2011
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.