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

Pancreatic Cancer Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endocrine Gland Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT00609765
• Study type: Interventional
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Status: Terminated
• Phase: Phase 2
• Start date: August 2007
• Completion date: March 2008