Full Text View
Tabular View
No Study Results Posted
Related Studies
Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors
This study has been terminated.
First Received: January 24, 2008   Last Updated: August 18, 2008   History of Changes
Sponsors and Collaborators: H. Lee Moffitt Cancer Center and Research Institute
Genentech
Information provided by: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00609765
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Avastin, Fluorouracil, Doxorubicin, Streptozocin
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Fluorouracil Streptozocin Doxorubicin Doxorubicin hydrochloride Myocet Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase II Study of Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors

Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • To assess progression-free survival (PFS) rate at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: August 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Prospective, single arm, Phase II
Drug: Avastin, Fluorouracil, Doxorubicin, Streptozocin

PROTOCOL SPECIFIED CHEMOTHERAPY

Every 28 Days:

  • Fluorouracil 400mg/m2 iv bolus daily days 1-5
  • Doxorubicin 40mg/m2 iv bolus day 1
  • Streptozocin 400mg/m2 iv bolus daily days 1-5
  • Avastin 5mg/kg iv days 1 and 15

Premedications:

  • Dexamethasone 20mg intravenously days 1-5
  • Odansetron 16mg intravenously days 1-5

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00609765

Locations
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Genentech
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute ( Larry Kvols, M.D. )
Study ID Numbers: MCC-14961, AVF3915s, USFIRB#105337d
Study First Received: January 24, 2008
Last Updated: August 18, 2008
ClinicalTrials.gov Identifier: NCT00609765     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
advanced
unresectable
metastatic
endocrine
tumors

Study placed in the following topic categories:
Antimetabolites
Dexamethasone
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Adenoma, Islet Cell
Bevacizumab
Streptozocin
Angiogenesis Inhibitors
Immunosuppressive Agents
Doxorubicin
Anti-Bacterial Agents
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenoma
Dexamethasone acetate
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Bevacizumab
Antibiotics, Antineoplastic
Neoplasms by Site
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Endocrine Gland Neoplasms
Neoplasms by Histologic Type
Digestive System Neoplasms
Growth Substances
Endocrine System Diseases
Adenoma, Islet Cell
Streptozocin
Angiogenesis Inhibitors
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Fluorouracil
Pancreatic Diseases
Adenoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009