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NCT00569127 · ClinicalTrials.gov registry record · Phase 3
Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor
A Phase 3 study of Neuroendocrine Tumor and Neuroendocrine Neoplasm, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 427
- Enrollment target
- 20
- Study locations
NCT00569127: Active Phase 3 study of Neuroendocrine Tumor and Neuroendocrine Neoplasm, sponsored by National Cancer Institute (NCI).
NCT00569127 is a Phase 3 study of Neuroendocrine Tumor and Neuroendocrine Neoplasm that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 427 participants, above the 73-participant average among 6 other Neuroendocrine Tumor trials with a reported enrollment target (485% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00569127, a Phase 3 study of Neuroendocrine Tumor and Neuroendocrine Neoplasm, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 427 participants
- Enrollment target
- 20
- Study locations
Study Summary
This 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.
Primary Outcome
From date of randomization (which is the date of registration) to date of first documentation of progression based on Central Radiological Review of the appropriate CT or MRI scans, or symptomatic deterioration (as defined in Section 10.2e)), or development of new lesions or disease not identified on CT or MRI, or death due to any cause. Patients who have a local assessment of progression based on imaging, but for whom central review does not concur, will be censored at the last Central Radiolog
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Bevacizumab
- DRUG Octreotide Acetate
- BIOLOGICAL Recombinant Interferon Alfa-2b
Study Locations (20)
California
- Kaiser Permanente-Anaheim - Anaheim
- Arroyo Grande Community - Arroyo Grande
- PCR Oncology - Arroyo Grande
- Kaiser Permanente-Baldwin Park - Baldwin Park
- Kaiser Permanente-Bellflower - Bellflower
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Mills-Peninsula Medical Center - Burlingame
- Kaiser Permanente-Fontana - Fontana
- Marin General Hospital - Greenbrae
- Kaiser Permanente South Bay - Harbor City
- Kaiser Permanente-Irvine - Irvine
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Los Angeles General Medical Center - Los Angeles
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- University of Arkansas for Medical Sciences - Little Rock
- Highlands Oncology Group - Rogers - Rogers
Alabama
- Providence Hospital - Mobile
Alaska
- Fairbanks Memorial Hospital - Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 427 participants |
| Start Date | 2007-12-01 |
| Est. Completion | 2027-01-31 |
| Phase | Phase 3 |
What the registry record for NCT00569127 still lists
NCT00569127 is an interventional study that assigns participants to a tested intervention. The registered 427 participants enrollment target is mid-sized for trials with a published cap, above the 73-participant average among 6 other Neuroendocrine Tumor trials with a reported enrollment target (485% higher).
The record links to 5 conditions, with Neuroendocrine Tumor appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00569127 names 20 study sites across 4 states, led by California, Arkansas, Alabama.
Frequently Asked Questions
What is clinical trial NCT00569127 about?
NCT00569127 is a clinical study titled "Octreotide Acetate and Recombinant Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor". This 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 whe...
What is the current status of trial NCT00569127?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 427 participants. The study started on 2007-12-01. Estimated completion is 2027-01-31.
What conditions does trial NCT00569127 study?
This clinical trial studies the following conditions: Neuroendocrine Tumor, Neuroendocrine Neoplasm, Neuroendocrine Tumor G2, Colorectal Neuroendocrine Tumor G1, Gastric Neuroendocrine Tumor G1.
What interventions are being tested in trial NCT00569127?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Bevacizumab (BIOLOGICAL), Octreotide Acetate (DRUG), Recombinant Interferon Alfa-2b (BIOLOGICAL).
Who is sponsoring clinical trial NCT00569127?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00569127 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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