Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors|
- Number of Participants With Progression Free Survival (PFS) at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]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).
- The Number of Participants With Radiographic Response [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Objective Radiographic Response Rate (ORR). We planned to calculate the sum of complete response (CR) and partial response (PR) in target lesions.
|Study Start Date:||August 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Experimental: Protocol Specified Chemotherapy
Protocol Specified Chemotherapy Every 28 Days: Avastin, Fluorouracil, Doxorubicin, Streptozocin.
Premedications: Dexamethasone, Ondansetron
Every 28 Days: Avastin 5mg/kg iv days 1 and 15
Other Name: bevacizumabDrug: Fluorouracil
Every 28 Days: Fluorouracil 400mg/m^2 iv bolus daily days 1-5
Other Names:Drug: Doxorubicin
Every 28 Days: Doxorubicin 40mg/m^2 iv bolus day 1
Other Name: Adriamycin®Drug: Streptozocin
Every 28 Days: Streptozocin 400mg/m2 iv bolus daily days 1-5
Other Name: Zanosar®Drug: Dexamethasone
Premedication: Dexamethasone 20mg intravenously days 1-5
Other Name: DecadronDrug: Ondansetron
Premedication: Ondansetron 16mg intravenously days 1-5
Other Name: Zofran
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609765
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Larry Kvols, M.D.||H. Lee Moffitt Cancer Center and Research Institute|
|Principal Investigator:||Jonathan Strosberg, M.D.||H. Lee Moffitt Cancer Center and Research Institute|