Conditions: Pancreatic Cancer
Keywords: advanced unresectable metastatic endocrine tumors
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 1
Healthy volunteers: no

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

Arms:
arm 1: Protocol Specified Chemotherapy Every 28 Days: Avastin, Fluorouracil, Doxorubicin, Streptozocin.

Premedications: Dexamethasone, Ondansetron

Interventions: intervention 1: Avastin intervention 2: Fluorouracil intervention 3: Doxorubicin intervention 4: Streptozocin intervention 5: Dexamethasone intervention 6: Ondansetron
Intervention descriptions: intervention 1: Every 28 Days: Avastin 5mg/kg iv days 1 and 15 intervention 2: Every 28 Days: Fluorouracil 400mg/m\^2 iv bolus daily days 1-5 intervention 3: Every 28 Days: Doxorubicin 40mg/m\^2 iv bolus day 1 intervention 4: Every 28 Days: Streptozocin 400mg/m2 iv bolus daily days 1-5 intervention 5: Premedication: Dexamethasone 20mg intravenously days 1-5 intervention 6: Premedication: Ondansetron 16mg intravenously days 1-5

Protocol document: