Expired Study
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Tampa, Florida 33612


Purpose:

Open label, single-arm phase II study of avastin combined with fluorouracil, doxorubicin and streptozocin administered in 28-day cycles. Treatment will continue until progression of disease, or until withdrawal due to toxicity, or up to a maximum of 12 cycles (48 weeks). In order to reduce the risk of cardiac toxicity, doxorubicin will be administered for a maximum of 8 cycles. If disease has not progressed after 12 cycles of treatment, avastin monotherapy will continue until disease progression or withdrawal due to toxicity.


Study summary:

Patients will need to come for 24 study visits in all. Most study visits will take about 2 hours. At some of these study visits, the doctor - Will do a physical exam - Will take blood for routine lab tests - Will do a urinalysis - Will administer study medication Some study visits may be longer because patient will have a CT scan or an MRI. At patient's last visit, they will have a CT scan or MRI. After treatment starts, patient will: - Have their blood pressure monitored with every dose of Avastin® (about every 2 weeks). - Have a history and physical with every chemotherapy cycle (about every 4 weeks). - Have their blood taken for routine blood tests with every chemotherapy cycle (about every 4 weeks). - Have a CT scan or MRI during every other cycle (about every 8 weeks). - Have a MUGA scan during every 4 cycles (about 16 weeks). - Have blood taken for tumor markers during every cycle only if their markers were high at baseline. - Patients will receive study medication to treat their cancer: - Fluorouracil on days 1 through 5 of each cycle through cycle 12 - Doxorubicin on day 1 of each cycle through cycle 8 - Streptozocin on days 1 through 5 of each cycle through cycle 12 - Avastin® on days 1 and 15 of each cycle through cycle 12


Criteria:

Inclusion Criteria: - Patients must have locally advanced (unresectable) or metastatic, well or moderately differentiated pancreatic endocrine tumors. - Measurable disease on CT scan or MRI. - Age ≥ 18 years and ≤ 80 years. - Use of effective means of contraception (men and women) in subjects of child-bearing potential - Adequate renal function (serum creatinine ≤1.5, urine protein:creatinine ratio <1.0 or urine dipstick for proteinuria < 2+ (patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1 g of protein in 24 hours to be eligible). - Adequate hepatic function (bilirubin ≤2.0, AST and ALT ≤ 3x ULN. - Adequate hematologic function (WBC ≥ 3,000, ANC ≥ 1500, platelets ≥ 100,000) Exclusion Criteria: - Prior therapy with fluorouracil, doxorubicin, streptozocin or avastin - Ejection fraction on MUGA <50% - ECOG performance status > 2 - Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored avastin cancer study - Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications) - Any prior history of hypertensive crisis or hypertensive encephalopathy - Unstable angina - New York Heart Association (NYHA) Grade II or greater congestive heart failure - History of myocardial infarction or unstable angina within 6 months prior to study enrollment - History of stroke or transient ischemic attack within 6 months prior to study enrollment - Significant vascular disease (e.g., aortic aneurysm, aortic dissection) - Symptomatic peripheral vascular disease - Evidence of bleeding diathesis or coagulopathy - Presence of central nervous system or brain metastases - Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study - Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment - Pregnant (positive pregnancy test) or lactating. Use of effective means of contraception (men and women) in subjects of child-bearing potential - Proteinuria at screening as demonstrated by either - Urine protein: creatinine (UPC) ratio ≥ 1.0 at screening OR - Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible). - History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0 - Evidence of duodenal invasion on CT scan, MRI, or endoscopy - Known hypersensitivity to any component of avastin - Serious, non-healing wound, ulcer, or bone fracture - Inability to comply with study and/or follow-up procedures


NCT ID:

NCT00609765


Primary Contact:

Principal Investigator
Larry Kvols, M.D.
H. Lee Moffitt Cancer Center and Research Institute


Backup Contact:

N/A


Location Contact:

Tampa, Florida 33612
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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