NCT00055809

Bevacizumab and PEG-Interferon Alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors

Phase II Study Of Bevacizumab And PEG Interferon Alpha-2b (PEG Intron) In Patients With Metastatic, Or Unresectable Carcinoid Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial is to see if combining bevacizumab with PEG-interferon alfa-2b works in treating patients who have metastatic or unresectable carcinoid tumors. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. PEG-interferon alfa-2b may stop the growth of cancer by stopping blood flow to the tumor. Combining bevacizumab with PEG-interferon alfa-2b may kill more cancer cells

Detailed description

OBJECTIVES: I. Determine the progression-free survival rate in patients with metastatic or unresectable carcinoid tumors treated with bevacizumab and PEG-interferon alfa-2b. II. Determine the tumor response rate (complete and partial) in patients treated with this regimen. III. Determine the biochemical response rate of patients treated with this regimen. IV. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients. OUTLINE: This is a randomized study. Patients are treated in 2 stages. Stage I: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive bevacizumab IV on day 1. Arm II: Patients receive PEG-interferon alfa-2b subcutaneously (SC) on days 1, 8, and 15. In both arms, courses repeat every 3 weeks. Patients with progressive disease at 9 weeks proceed to stage II. All other patients proceed to stage II after 18 weeks on stage I. Stage II: Patients receive bevacizumab IV on day 1 and PEG-interferon alfa-2b SC once weekly. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) and remain in CR for 2 additional courses come off study. Patients are followed for survival.

Conditions

• Metastatic Gastrointestinal Carcinoid Tumor
• Recurrent Gastrointestinal Carcinoid Tumor
• Regional Gastrointestinal Carcinoid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	PEG-interferon alfa-2b	Given SC
BIOLOGICAL	bevacizumab	Given IV
OTHER	laboratory biomarker analysis	Optional correlative studies

Timeline

• Start date: 2003-01-01
• Primary completion: 2007-06-01
• First posted: 2003-03-07
• Last updated: 2013-01-23

Locations

1 site across 1 country: United States