Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors
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|ClinicalTrials.gov Identifier: NCT00609765|
Recruitment Status : Terminated (Development of new chemotherapy standard of care for treatment rendered the trial obsolete.)
First Posted : February 7, 2008
Results First Posted : March 22, 2011
Last Update Posted : March 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Avastin Drug: Fluorouracil Drug: Doxorubicin Drug: Streptozocin Drug: Dexamethasone Drug: Ondansetron||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
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: bevacizumab
Every 28 Days: Fluorouracil 400mg/m^2 iv bolus daily days 1-5
Every 28 Days: Doxorubicin 40mg/m^2 iv bolus day 1
Other Name: Adriamycin®
Every 28 Days: Streptozocin 400mg/m2 iv bolus daily days 1-5
Other Name: Zanosar®
Premedication: Dexamethasone 20mg intravenously days 1-5
Other Name: Decadron
Premedication: Ondansetron 16mg intravenously days 1-5
Other Name: Zofran
- Number of Participants With Progression Free Survival (PFS) at 12 Months [ Time Frame: 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).
- The Number of Participants With Radiographic Response [ Time Frame: 2 years ]Objective Radiographic Response Rate (ORR). We planned to calculate the sum of complete response (CR) and partial response (PR) in target lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|