Bevacizumab and PEG-Interferon Alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors
Completed · Phase 2
Conditions studied: Metastatic Gastrointestinal Carcinoid Tumor, Recurrent Gastrointestinal Carcinoid Tumor, Regional Gastrointestinal Carcinoid Tumor
In brief
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
Key facts
- Study ID
- NCT00055809
- Run by
- National Cancer Institute (NCI)
- People needed
- 44
- Starts
- 2003-01-01
- Last updated by the study team
- 2013-01-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed carcinoid tumor
- Metastatic or unresectable local-regional disease
- Measurable disease
- No osseous metastasis as the only site of disease
- No history or clinical evidence of CNS disease (e.g., primary brain tumor or any brain metastasis)
- Performance status - Zubrod 0-2
- Performance status - Karnofsky 70-100%
- At least 12 weeks
- See Immunologic
- Absolute granulocyte count > 1,500/mm\^3
- Platelet count > 100,000/mm\^3
- Hemoglobin > 8 g/dL
- No bleeding diathesis or coagulopathy
- No hemoglobinopathies (e.g., thalassemia) or any other cause of hemolytic anemia
- Bilirubin < 1.5 mg/dL
- INR < 1.5 (if receiving warfarin)
- No evidence of decompensated liver disease (e.g., ascites, bleeding varices, or spontaneous encephalopathy)
- Creatinine < 1.5 mg/dL
- No baseline proteinuria
- Patients with proteinuria (≥ 2+ or ≥ 100 mg/dL on urinalysis) are allowed provided 24-hour urinary protein is < 500 mg
- No New York Heart Association grade II-IV congestive heart failure
- No serious cardiac arrhythmia requiring medication
- No clinically significant peripheral vascular disease
- No history of stroke
- None of the following within the past 6 months:
Where it is running
- M D Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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