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Type(s) of Cancer
Neuroendocrine
Study Phase
Phase 3
Study Completion Date
January 2015
NCT00569127Uploaded 02-24-2018
Access via NCI by Request
PDS UID: nci-data-371
Phase III Prospective Randomized Comparison of Depot Octreotide Plus Interferon Alpha Versus Depot Octreotide Plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
Provider Information
Provider Data DescriptionThis dataset will allow users to reproduce toxicity analyses reported in the Journal of Clinical Oncology (Yao et al., JCO, 2017, PMID referenced above), which included adverse events among patients with advanced NETs in the SWOG Phase III trial, S0518 (NCT00569127), receiving bevacizumab + octreotide or interferon alfa-2b + octreotide.
SponsorNational Cancer Institute
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies octreotide acetate and recombinant interferon alfa-2b to see how well it works compared to octreotide acetate and bevacizumab in treating patients with high-risk neuroendocrine tumors that have spread to other places in the body (metastatic) or spread from where it started to nearby tissue or lymph nodes (locally advanced). Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving octreotide acetate together with recombinant interferon alfa-2b is more effective than giving octreotide acetate together with bevacizumab in treating patients with neuroendocrine tumor.
ConditionsAtypical Carcinoid Tumor
Carcinoid Tumor
Colorectal Neuroendocrine Tumor G1
Gastric Neuroendocrine Tumor G1
Neuroendocrine Neoplasm
Intervention TypeBiological: Bevacizumab
Other: Laboratory Biomarker Analysis
Drug: Octreotide Acetate
Biological: Recombinant Interferon Alfa-2b
Drug(s)Drug: Octreotide Acetate
Total Enrolled427
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm I (octreotide acetate and bevacizumab) - Experimental
Arm II (octreotide acetate and recombinant interferon alfa-2b) - Experimental
Secondary IDNCI-2009-00778
PubMed (PMID)28384065
Collaborator(s)N/A
Region(s)United States
Age RangeN/A (Child, Adult, Older Adult)
Files: NCT00569127-D2
Data DictionaryNCT00569127-D2-Data-Dictionary.pdf
DATANCT00569127-D2-Dataset.csv
OTHERREADME.pdf
Files: NCT00569127-D1
Data DictionaryNCT00569127-D1-Data-Dictionary.pdf
DATANCT00569127-D1-Dataset.csv
OTHERREADME.pdf
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