Bevacizumab and PEG-Interferon Alfa-2b in Treating Patients With Metastatic or Unresectable Carcinoid Tumors
Metastatic Gastrointestinal Carcinoid Tumor, Recurrent Gastrointestinal Carcinoid Tumor, Regional Gastrointestinal Carcinoid Tumor
About this trial
This is an interventional treatment trial for Metastatic Gastrointestinal Carcinoid Tumor
Eligibility Criteria
Inclusion Criteria: 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: Uncontrolled hypertension Transient ischemic attack Cerebrovascular accident Unstable angina Myocardial infarction No chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) No documented pulmonary hypertension None of the following immunologically mediated diseases: Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) Rheumatoid arthritis Idiopathic thrombocytopenia purpura Systemic lupus erythematosus Autoimmune hemolytic anemia Scleroderma Severe psoriasis No serious concurrent infections No active infection requiring parental antibiotics on day 0 No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies No known hypersensitivity to interferon alfa or to any excipient or vehicle included in its formulation or delivery system Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant traumatic injury within the past 4 weeks No preexisting thyroid abnormality for which thyroid function can not be normalized by medication No concurrent nonmalignant uncontrolled medical illness or one whose control may be jeopardized by the complications of this study therapy No uncontrolled psychiatric disorder No psychiatric disorders that would preclude study compliance No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix No serious nonhealing wound ulcer or bone fracture No seizures not controlled with standard medical therapy Prior immunotherapy allowed No prior interferon No concurrent immunotherapy At least 4 weeks since prior chemotherapy, including radiosensitizers No more than 1 prior chemotherapy regimen, including radiosensitizers No concurrent chemotherapy At least 4 weeks since prior radiotherapy Prior radiotherapy must not have contained the single evaluable lesion of this study in a radiation field No concurrent radiotherapy At least 4 weeks since prior major surgery or open biopsy (1 week for minor surgery) and recovered No concurrent or recent full-dose anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters) No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (bevacizumab)
Arm II (PEG-interferon alfa-2b)
Patients receive bevacizumab IV on day 1.
Patients receive PEG-interferon alfa-2b SC on days 1, 8, and 15.