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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00569127 |
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.
Condition | Intervention | Phase |
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Neuroendocrine Carcinoma |
Drug: bevacizumab Drug: octreotide acetate Drug: recombinant interferon alfa-2b |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients |
Estimated Enrollment: | 283 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I (octreotide acetate and bevacizumab): Experimental
Patients receive depot octreotide acetate intramuscularly (IM) and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: bevacizumab
Given IV
Drug: octreotide acetate
Given intramuscularly
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Arm II (octreotide acetate and interferon alfa-2b): Active Comparator
Patients receive octreotide acetate IM as in arm I on day 1 and interferon alfa-2b subcutaneously (SC) on days 1, 3, 5, 8, 10, 12, 15, 17, and 19. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
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Drug: octreotide acetate
Given intramuscularly
Drug: recombinant interferon alfa-2b
Given subcutaneously
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OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to site of disease (small bowel vs cecum vs appendix vs other site), disease progression after initial diagnosis (yes or no), histologic grade (low vs intermediate [atypical]), and prior octreotide acetate therapy within the past 2 months (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Treatment in both arms repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 2-6 months for up to 3 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Diagnosis of unresectable metastatic or locally advanced, low- or intermediate-grade neuroendocrine carcinoma, including the following subtypes:
High-risk disease as defined by at least one of the following:
Metastatic colorectal carcinoid tumor
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Recent history (i.e., within the past 6 months) of any of the following arterial thromboembolic events:
Any immunologically mediated disease, including any of the following:
PRIOR CONCURRENT THERAPY:
At least 28 days since prior hepatic artery embolization provided there is residual measurable disease
At least 28 days since prior radiotherapy
Concurrent full-dose anticoagulation (warfarin or low molecular weight heparin) allowed provided the following criteria are met:
No concurrent interferon to control carcinoid syndrome for patients receiving bevacizumab
Study Chair: | James Yao, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000579151, SWOG-S0518 |
Study First Received: | December 5, 2007 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00569127 |
Health Authority: | Unspecified |
neuroendocrine carcinoma |
Interferon-alpha Interferon Type I, Recombinant Carcinoma, Neuroendocrine Interferons Octreotide Bevacizumab Carcinoma Neuroendocrine Tumors Carcinoid tumor |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma Carcinoid Tumor Adenocarcinoma Interferon Alfa-2a Interferon Alfa-2b Neoplasms, Glandular and Epithelial |
Anti-Infective Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immunologic Factors Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Physiological Effects of Drugs |
Gastrointestinal Agents Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |