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Open Trial of Bendamustine Hydrochloride in Women With Advanced Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT00867503
First received: March 20, 2009
Last updated: December 5, 2012
Last verified: September 2012
History of Changes
Results First Received: October 1, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ovarian Cancer
Intervention: Drug: Bendamustine HCL

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bendamustine Bendamustine Hydrochloride (HCL) 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.

Participant Flow:   Overall Study
    Bendamustine  
STARTED     10  
COMPLETED     9  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Bendamustine bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.

Baseline Measures
    Bendamustine  
Number of Participants  
[units: participants]
 		  10  
Age  
[units: years]
Median ( Full Range ) 		  58  
  ( 34 to 82 )  
Gender  
[units: participants]
 		 
Female     10  
Male     0  
Ethnicity (NIH/OMB)  
[units: Participants]
 		 
Hispanic or Latino     5  
Not Hispanic or Latino     5  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: Participants]
 		 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     10  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 		 
United States     10  
Primary Site  
[units: participants]
 		 
Ovarian     9  
Peritoneal     1  
Median number of prior regimens  
[units: Regimens]
Median ( Full Range ) 		  5  
  ( 3 to 10 )  
Eastern Cooperative Oncology Group performance status [1]
[units: Participants]
 		 
0     9  
1     1  
Tumor Grade [2]
[units: Participants]
 		 
2     2  
3     8  
Cell Type  
[units: Participants]
 		 
Serous     6  
Endometrioid     3  
Clear Cell     1  
[1] Eastern Cooperative Oncology Group (ECOG) performance status is a scale 0-5. A score of 0 indicates fully active, able to carry on all pre-disease performance without restriction; 1 indicates restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature; For more information on the ECOG performance scale refer to Oken, M.M., Creech, R.H., Tormey, D.C., Horton, J., Davis, T.E., McFadden, E.T., Carbone, P.P.: Toxicity And Response Criteria Of The Eastern Cooperative Oncology Group. Am J Clin Oncol 5:649-655, 1982.
[2]

Criteria met for determination of Grade:

Grade 1: the least malignant, with well-differentiated cells Grade 2: intermediate, with moderately differentiated cells Grade 3: the most malignant, with poorly differentiated cells



  Outcome Measures
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1.  Primary:   Progression Free Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.   [ Time Frame: life of the study ]
  Show Outcome Measure 1

2.  Primary:   Overall Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.   [ Time Frame: Life of study ]
  Show Outcome Measure 2

3.  Secondary:   Toxicities of Patients Treated With Bendamustine.   [ Time Frame: Life of the study ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The team was not able to collect fresh tumor tissue at the time of the study, so we could not examine patient tumors to determine their DNA repair capabilities.  


Results Point of Contact:  
Name/Title: Dr. Setsuko K Chambers
Organization: University Of Arizona
phone: 520/626-0950
e-mail: schambers@azcc.arizona.edu


No publications provided


Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00867503     History of Changes
Other Study ID Numbers: 08-1137-04
Study First Received: March 20, 2009
Results First Received: October 1, 2012
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration