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Avastin, Fluorouracil, Doxorubicin and Streptozocin in Locally Advanced and Metastatic Pancreatic Endocrine Tumors

NCT00609765 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-03-23

Study results available
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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.

Conditions

Interventions

DRUG

Avastin

Every 28 Days: Avastin 5mg/kg iv days 1 and 15

DRUG

Fluorouracil

Every 28 Days: Fluorouracil 400mg/m\^2 iv bolus daily days 1-5

DRUG

Doxorubicin

Every 28 Days: Doxorubicin 40mg/m\^2 iv bolus day 1

DRUG

Streptozocin

Every 28 Days: Streptozocin 400mg/m2 iv bolus daily days 1-5

DRUG

Dexamethasone

Premedication: Dexamethasone 20mg intravenously days 1-5

DRUG

Ondansetron

Premedication: Ondansetron 16mg intravenously days 1-5

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Larry Kvols, M.D. · H. Lee Moffitt Cancer Center and Research Institute

  • Jonathan Strosberg, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00609765 on ClinicalTrials.gov