Phase II Study of Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors
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
- 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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Participants With Progression Free Survival (PFS) at 12 Months
We planned to calculate the One Year Progression Free Survival rate. The event for PFS analyses was the first occurrence of disease progression or death and patients who did not progress or died would be censored at the date of last tumor evaluation (e.g. one-year).
Larry Kvols, M.D.
H. Lee Moffitt Cancer Center and Research Institute
United States: Institutional Review Board
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