A Study of Axitinib in Advanced Carcinoid Tumors

Exclusion Criteria

• •Poorly differentiated, high-grade (e.g. small cell or large cell) neuroendocrine carcinomas are excluded.
• •Pancreatic neuroendocrine tumors (NETs), paragangliomas, pheochromocytomas and medullary thyroid cancers are excluded.
• •Adenocarcinoid tumors and goblet cell carcinoid tumors are excluded.
• •Prior antiangiogenic therapy with a dedicated vascular endothelial growth factor (VEGF) pathway inhibitor
• •Clinically apparent central nervous system metastases
• •Any of the following within 12 months prior to study: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
• •Deep venous thrombosis or pulmonary embolism within 6 months of study
• •Major surgery 4 weeks prior to enrollment
• •Inability to take oral medication or prior surgical procedures affecting absorption (including total gastric resection)
• •Active gastrointestinal bleeding, if transfusion dependent
• •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
• •History of pulmonary hemorrhage or evidence of significant hemoptysis
• •History of serious non-healing wound, ulcer, or bone fracture within the past 28 days
• •Pre-existing thyroid abnormality allowed provided thyroid function can be controlled with medication.
• •Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, etc.)
• •Current use or anticipated need for treatment with drugs that are known inducers of CYP3AR or CYP1A2 (i.e carbamazepine, dexamethasone, omeprazole, phenobarbital, phenytoin, rifampin, St. John's Wart, etc.)
• •Uncontrolled serious medical or psychiatric illness. Patients with a "currently active" second malignancy other than non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer (staged pathological tumor-2 (pT2) with Gleason Score ≤ 6 and postoperative prostatic specific antigen (PSA) \< 0.5 ng/mL), or other adequately treated carcinoma-in-situ are ineligible. Patients are not considered to have a "currently active" malignancy if they have completed therapy and are free of disease for ≥3 years.
• •Pregnant or lactating women, or adults of reproductive potential who are not using effective birth-control methods.
• •Prior antitumor therapy within 4 weeks of enrollment (with exception of somatostatin analogs)
• •Liver-directed therapy within 2 months of enrollment. Prior treatment with radiotherapy (including radio-labeled spheres and/or cyberknife, hepatic arterial embolization (with or without chemotherapy) or cryotherapy/ablation is allowed if these therapies did not affect the areas of measurable disease being used for this protocol or if progressive disease can be documented in the previously treated area.
• •Recent infection requiring systemic anti-infective treatment that was completed ≤14 days prior to enrollment (with the exception of uncomplicated urinary tract infection or upper respiratory tract infection)
• •Uncontrolled hypertension (blood-pressure \>140/90). Patient with baseline hypertension may be eligible after initiation of antihypertensive therapy.