NCT00609765

Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors

Phase II Study of Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Avastin	Every 28 Days: Avastin 5mg/kg iv days 1 and 15
DRUG	Fluorouracil	Every 28 Days: Fluorouracil 400mg/m\^2 iv bolus daily days 1-5
DRUG	Doxorubicin	Every 28 Days: Doxorubicin 40mg/m\^2 iv bolus day 1
DRUG	Streptozocin	Every 28 Days: Streptozocin 400mg/m2 iv bolus daily days 1-5
DRUG	Dexamethasone	Premedication: Dexamethasone 20mg intravenously days 1-5
DRUG	Ondansetron	Premedication: Ondansetron 16mg intravenously days 1-5

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-02-07
• Last updated: 2017-03-23
• Results posted: 2011-03-22

Locations

1 site across 1 country: United States