- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00609765
Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors
Phase II Study of Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 Names:
Every 28 Days: Fluorouracil 400mg/m^2 iv bolus daily days 1-5
Other Names:
Every 28 Days: Doxorubicin 40mg/m^2 iv bolus day 1
Other Names:
Every 28 Days: Streptozocin 400mg/m2 iv bolus daily days 1-5
Other Names:
Premedication: Dexamethasone 20mg intravenously days 1-5
Other Names:
Premedication: Ondansetron 16mg intravenously days 1-5
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Larry Kvols, M.D., H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antibiotics, Antineoplastic
- Antipruritics
- Dexamethasone
- Fluorouracil
- Bevacizumab
- Doxorubicin
- Ondansetron
- Streptozocin
Other Study ID Numbers
- MCC-14961
- AVF3915s (Other Identifier: Genentech)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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