Metastatic Gastrointestinal Carcinoid Tumor Clinical Trial
Official title:
Phase II Study Of Bevacizumab And PEG Interferon Alpha-2b (PEG Intron) In Patients With Metastatic, Or Unresectable Carcinoid Tumors
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
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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