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Bevacizumab and Paclitaxel for Neuroendocrine Tumors of the Cervix

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00626561
Recruitment Status : Terminated (Due to slow accrual.)
First Posted : February 29, 2008
Results First Posted : July 7, 2014
Last Update Posted : July 7, 2014
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cervical Cancer
Uterine Cancer
Interventions Drug: Bevacizumab
Drug: Paclitaxel
Enrollment 4
Recruitment Details Recruitment Period: February 18, 2008 to November 04, 2010. All recruitment done at University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details Study was terminated early due to low accrual. One participant enrolled of four withdrew before being treatment.
Arm/Group Title Bevacizumab + Paclitaxel
Hide Arm/Group Description Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
Period Title: Overall Study
Started 4
Completed 0
Not Completed 4
Reason Not Completed
Withdrawal by Subject             2
Disease Progression             2
Arm/Group Title Bevacizumab + Paclitaxel
Hide Arm/Group Description Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
One participant not treated.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
33
(32 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
4
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Progression-free Survival (PFS)
Hide Description Progression-Free Survival is the period from study entry until disease progression, death or date of last contact.
Time Frame Baseline to 6 Months, or until disease progression.
Hide Outcome Measure Data
Hide Analysis Population Description
Interim analysis was to be done after 10 patients enrolled, accrual not met. Study halted early.
Arm/Group Title Bevacizumab + Paclitaxel
Hide Arm/Group Description:
Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data obtained every cycle (approximately every 4 weeks) until 30 days post treatment. Overall study period 2 years, May 2008 to May 2010.
Adverse Event Reporting Description One participant of four was enrolled but not treated therefore excluded from adverse event reporting.
 
Arm/Group Title Bevacizumab + Paclitaxel
Hide Arm/Group Description Bevacizumab 10 mg/kg intravenous (IV) twice weekly and Paclitaxel 60 mg/m^2 IV weekly.
All-Cause Mortality
Bevacizumab + Paclitaxel
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Bevacizumab + Paclitaxel
Affected / at Risk (%)
Total   0/3 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab + Paclitaxel
Affected / at Risk (%)
Total   3/3 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  1/3 (33.33%) 
Gastrointestinal disorders   
Constipation  1  2/3 (66.67%) 
Nausea  1  1/3 (33.33%) 
General disorders   
Pain  1  2/3 (66.67%) 
Fatigue  1  3/3 (100.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Michael M. Frumovitz, MD / Professor, Gynecologic Oncology
Organization: University of Texas MD Anderson Cancer Center
Phone: 713-792-9599
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00626561    
Other Study ID Numbers: 2007-0324
First Submitted: February 20, 2008
First Posted: February 29, 2008
Results First Submitted: June 5, 2014
Results First Posted: July 7, 2014
Last Update Posted: July 7, 2014