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Trial record 19 of 1297 for:    survival | Neuroendocrine Tumors

Bevacizumab and Paclitaxel for Neuroendocrine Tumors of the Cervix

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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   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab + Paclitaxel
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events 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
Name/Title: Michael M. Frumovitz, MD / Professor, Gynecologic Oncology
Organization: University of Texas MD Anderson Cancer Center
Phone: 713-792-9599
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00626561     History of Changes
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