Study on Octreotide Acetate and Interferon Alfa-2b or Bevacizumab for Treating Advanced Neuroendocrine Tumors
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT00569127
This clinical trial is comparing two treatment combinations to see which is more effective for patients with high-risk neuroendocrine tumors that have spread or are locally advanced. The study aims to determine if octreotide acetate with interferon alfa-2b works better than octreotide acetate with bevacizumab.
Patient Parameters
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Program Overview
This study is testing two different treatment combinations for patients with high-risk neuroendocrine tumors that have either spread to other parts of the body or are locally advanced. The treatments being compared are octreotide acetate with recombinant interferon alfa-2b and octreotide acetate with bevacizumab. The goal is to see which combination is more effective at slowing down or stopping the growth of these tumors.
Description
The main goal of this study is to compare how long patients live without their cancer getting worse when treated with either octreotide acetate and bevacizumab or octreotide acetate and interferon alfa-2b. Researchers will also look at overall survival, how long patients stay on treatment before it stops working, and the side effects of each treatment.
Patients will be randomly assigned to one of two groups:
- Group 1: Receives octreotide acetate and bevacizumab.
- Group 2: Receives octreotide acetate and interferon alfa-2b.
Both treatments are given in cycles every 21 days, as long as the cancer does not progress or side effects are manageable.
After finishing the study treatment, patients will have follow-up visits every 2-6 months for up to 3 years to monitor their health and cancer status.
Eligibility Criteria
Inclusion Criteria
- Must have advanced neuroendocrine tumors that cannot be surgically removed or have spread.
- Tumors must be classified as low or intermediate grade, such as carcinoid or well-differentiated neuroendocrine carcinoma.
- Must have high-risk disease, such as progressive disease, refractory carcinoid syndrome, atypical histology with multiple lesions, or certain types of metastatic carcinoid.
- Must have measurable disease confirmed by recent scans.
- Must provide tumor tissue samples for review.
- May have had one prior chemotherapy regimen, but must have recovered from its effects.
- Must not have received prior interferon, bevacizumab, or similar therapies.
- Must have good overall health, with specific blood counts and organ function within normal limits.
- Women of childbearing potential must use effective birth control during and after treatment.
- Must not have other serious health conditions or recent history of certain medical events.
- Must not be pregnant or nursing.
- Must agree to follow study procedures and provide informed consent.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Providence Hospital | 36608 | Mobile | Alabama |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Mercy Hospital Fort Smith | 72903 | Fort Smith | Arkansas |
| NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro | 72401 | Jonesboro | Arkansas |
| University of Arkansas for Medical Sciences | 72205 | Little Rock | Arkansas |
| Highlands Oncology Group - Rogers | 72758 | Rogers | Arkansas |
| Kaiser Permanente-Anaheim | 92806 | Anaheim | California |
| Arroyo Grande Community | 93420 | Arroyo Grande | California |
| PCR Oncology | 93420 | Arroyo Grande | California |
| Kaiser Permanente-Baldwin Park | 91706 | Baldwin Park | California |
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