Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors
Information source: H. Lee Moffitt Cancer Center and Research Institute
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pancreatic Cancer
Intervention: Avastin, Fluorouracil, Doxorubicin, Streptozocin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: H. Lee Moffitt Cancer Center and Research Institute Official(s) and/or principal investigator(s):
Larry Kvols, M.D., Principal Investigator, Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Jonathan Strosberg, M.D., Principal Investigator, Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Overall contact:
Larry Kvols, M.D., Phone: 813-745-3519, Email: larry.kvols@moffitt.org
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 Details
Official title: Phase II Study of Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: To assess progression-free survival (PFS) rate at 12 months.
Secondary outcome: Assess radiographic response rate, biochemical response rate, median progression-free survival, overall survival, duration of response, one and two year survival rates, and toxicities associated with the regimen.
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
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients must have locally advanced (unresectable) or metastatic, well or moderately
differentiated pancreatic endocrine tumors.
- Measurable disease on CT scan or MRI.
- Age ≥ 18 years and ≤ 80 years.
- Use of effective means of contraception (men and women) in subjects of child-bearing
potential
- Adequate renal function (serum creatinine ≤1. 5, urine protein: creatinine ratio <1. 0 or
urine dipstick for proteinuria < 2+ (patients discovered to have ≥ 2+ proteinuria on
dipstick urinalysis at baseline should undergo a 24 hour urine collection and must
demonstrate ≤ 1 g of protein in 24 hours to be eligible).
- Adequate hepatic function (bilirubin ≤2. 0, AST and ALT ≤ 3x ULN.
- Adequate hematologic function (WBC ≥ 3,000, ANC ≥ 1500, platelets ≥ 100,000)
Exclusion Criteria:
- Prior therapy with fluorouracil, doxorubicin, streptozocin or avastin
- Ejection fraction on MUGA <50%
- ECOG performance status > 2
- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study other than a Genentech-sponsored avastin
cancer study
- Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or
diastolic blood pressure > 100 mmHg on antihypertensive medications)
- Any prior history of hypertensive crisis or hypertensive encephalopathy
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to study
enrollment
- History of stroke or transient ischemic attack within 6 months prior to study
enrollment
- Significant vascular disease (e. g., aortic aneurysm, aortic dissection)
- Symptomatic peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to Day 0, anticipation of need for major surgical procedure during the course of
the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular
access device, within 7 days prior to study enrollment
- Pregnant (positive pregnancy test) or lactating. Use of effective means of
contraception (men and women) in subjects of child-bearing potential
- Proteinuria at screening as demonstrated by either
- Urine protein: creatinine (UPC) ratio ≥ 1. 0 at screening OR
- Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria
on dipstick urinalysis at baseline should undergo a 24 hour urine collection and
must demonstrate ≤ 1g of protein in 24 hours to be eligible).
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
within 6 months prior to Day 0
- Evidence of duodenal invasion on CT scan, MRI, or endoscopy
- Known hypersensitivity to any component of avastin
- Serious, non-healing wound, ulcer, or bone fracture
- Inability to comply with study and/or follow-up procedures
Locations and Contacts
Larry Kvols, M.D., Phone: 813-745-3519, Email: larry.kvols@moffitt.org
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida 33612, United States; Recruiting
Tiffany Campos, Phone: 813-745-8358, Email: tiffany.campos@moffitt.org
Larry Kvols, M.D., Principal Investigator
Jonathan Strosberg, M.D., Principal Investigator
Additional Information
Moffitt Cancer Center Clinical Trials website
Starting date: August 2007
Ending date: January 2010
Last updated: February 15, 2008
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