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Title:
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Phase III Prospective Randomized Comparison of Depot Octreotide plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients - IRB# 09-072B
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Treatments:
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Bevacizumab, Interferon alpha-2b, Octreotide
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Disease Site:
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Gastrointestinal
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Disease SubSite:
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Drug Provided:
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Bevacizumab
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Comments:
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01/26/10: Registration Step 2 (SPECT Substudy) is temporarily closed to accrual effective
immediately, due to a recall and lack of supply of Octreoscan™ kits. This substudy is
described in Sections 5.31-5.33, Section 15.1.b, and Appendix 19.6 of the protocol.
Until the substudy re-opens, institutions are NOT required to seek additional patient
consent for the substudy.
NOTE: The treatment study (Registration Step 1) remains open to accrual.
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Eligibility:
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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.
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Participating Sites:
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Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
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