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

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