A Combination Study to Determine the Safety and Efficacy of Panzem NCD With Avastin in Metastatic Carcinoid Tumors
Carcinoid Tumor
About this trial
This is an interventional treatment trial for Carcinoid Tumor
Eligibility Criteria
Inclusion Criteria: Histologically documented locally unresectable or metastatic carcinoid neuroendocrine tumor Measurable disease, according to RECIST, with at least one lesion that is unidimensionally measurable by conventional techniques to be greater than or equal to 2 cm in diameter, or by spiral CT to be greater than or equal to 1 cm in diameter 18 years or older Laboratory data to include (next 7 bullet points): Aspartate aminotransferase(AST)and alanine aminotransferase (ALT)less than 2.5 times the upper limit of normal (less than 5 times upper limit of normal if liver metastasis present) Total bilirubin less than or equal to 2 mg/dL Serum creatinine less than or equal to 1.5 mg/dL Total white blood cell count greater than 3,500/mm3 Absolute neutrophil count greater than or equal to 1,500/mm3 International normalized ratio less then or equal to 1.5 Platelets greater than or equal to 100,000/mm3 Agree to use effective contraceptive methods Have an ECOG performance status of less than 2 Life expectancy of greater than 12 weeks Ability to understand the requirements of the study, have provided written consent, and agree to abibe by the study restrictions Exclusion Criteria: Pregnant or nursing, or refusal to use appropriate birth control An active infection Have a history of myocardial infarction or angina pectoris/angina equivalent in the last 12 months (the patient may be on antianginal medications if the symptoms can be fully controlled), or have uncontrolled congestive heart failure Have apparent central nervous system metastasis or carcinomatous meningitis Have had any active cancer in addition to the carcinoid tumor within the last 5 years, with the exception of superficial skin cancer Be receiving concurrent treatment with therapeutic doses of any anticoagulant including all forms of heparin and Coumadin Have current or a history of severe bleeding Uncontrolled / severe hypertension Previous history of nephrotic syndrome Urine protein: creatinine ratio greater than or equal to 1.0 at screening Have received radiotherapy or chemotherapy within the previous 4 weeks Participated in any clinical trial involving conventional or investigational drugs or devices within the previous 4 weeks Have had major surgery within 4 weeks or plan to undergo elective surgery during treatment Additional uncontrolled serious medical condition or psychiatric illness Have any condition that is likely to interfere with regular follow-up
Sites / Locations
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Experimental
1
Panzem NCD will be dosed orally at a level of 1,000 mg, four times daily for 28 consecutive days and bevacizumab will be administered at a dose of 5 mg/kg as an intravenous bolus on Day 1 and Day 15 of the Treatment Period