Spots Global Cancer Trial Database for Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors

Study Description

Brief Summary: 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.

Detailed Description: 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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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