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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
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Avastin
Drug: Fluorouracil
Drug: Doxorubicin
Drug: Streptozocin
Drug: Dexamethasone
Drug: Ondansetron
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chemotherapy
Hide Arm/Group Description Prospective, single arm, Phase II
Period Title: Overall Study
Started 1
Completed 0
Not Completed 1
Reason Not Completed
Study ended prior to 12 months             1
Arm/Group Title Chemotherapy
Hide Arm/Group Description Prospective, single arm, Phase II
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title Number of Participants With Progression Free Survival (PFS) at 12 Months
Hide Description 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).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol at 12 months
Arm/Group Title Chemotherapy
Hide Arm/Group Description:
Prospective, single arm, Phase II
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title The Number of Participants With Radiographic Response
Hide Description Objective Radiographic Response Rate (ORR). We planned to calculate the sum of complete response (CR) and partial response (PR) in target lesions.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy
Hide Arm/Group Description:
Prospective, single arm, Phase II
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chemotherapy
Hide Arm/Group Description Prospective, single arm, Phase II
All-Cause Mortality
Chemotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy
Affected / at Risk (%)
Total   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Chemotherapy
Affected / at Risk (%)
Total   0/1 (0.00%) 
This trial only enrolled one patient and was closed because of development of a new chemotherapy standard of care for treatment of this cancer which we felt rendered the trial obsolete. The trial was open for only 7 months.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jonathan Strosberg, M.D.
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-2069
EMail: jonathan.strosberg@moffitt.org
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00609765     History of Changes
Other Study ID Numbers: MCC-14961
AVF3915s ( Other Identifier: Genentech )
First Submitted: January 24, 2008
First Posted: February 7, 2008
Results First Submitted: February 21, 2011
Results First Posted: March 22, 2011
Last Update Posted: March 23, 2017