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Trial record 1 of 315 for:    BENDAMUSTINE
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Open Trial of Bendamustine Hydrochloride in Women With Advanced Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT00867503
Recruitment Status : Completed
First Posted : March 23, 2009
Results First Posted : November 29, 2012
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
University of Arizona

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Intervention Drug: Bendamustine HCL
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bendamustine
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 10
Completed 9
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Bendamustine
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
58
(34 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
10
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Hispanic or Latino
5
  50.0%
Not Hispanic or Latino
5
  50.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
Primary Site  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
Ovarian 9
Peritoneal 1
Median number of prior regimens  
Median (Full Range)
Unit of measure:  Regimens
Number Analyzed 10 participants
5
(3 to 10)
Eastern Cooperative Oncology Group performance status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
0 9
1 1
[1]
Measure Description: 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.
Tumor Grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
2 2
3 8
[1]
Measure Description:

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

Cell Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
Serous 6
Endometrioid 3
Clear Cell 1
1.Primary Outcome
Title Progression Free Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria or Cancer Antigen (CA)125 response using the modified Gynecologic Cancer Intergroup(GCIG) criteria
Time Frame life of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bendamustine Median Progression Free Surivial in Months
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: Days
140
(23 to 316)
2.Primary Outcome
Title Overall Survival in Patients With Platinum and Taxane Refractory Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer With Bendamustine Treatment.
Hide Description [Not Specified]
Time Frame Life of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Median Overall Survival in Days
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 10
Median (Full Range)
Unit of Measure: Days
393
(234 to 925)
3.Secondary Outcome
Title Toxicities of Patients Treated With Bendamustine.
Hide Description Grade 4 Toxicity
Time Frame Life of the study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bendamustine Grade 4 Toxicity
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Partcipants
0
Time Frame Life of study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bendamustine
Hide Arm/Group Description 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.
All-Cause Mortality
Bendamustine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bendamustine
Affected / at Risk (%) # Events
Total   2/10 (20.00%)    
Gastrointestinal disorders   
Small Bowel Obstruction  1  2/10 (20.00%)  4
Abdominal Pain  1  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bendamustine
Affected / at Risk (%) # Events
Total   10/10 (100.00%)    
Blood and lymphatic system disorders   
Leukocytes  1  6/10 (60.00%) 
Neutrophils  1  5/10 (50.00%) 
Hemoglobin  1  5/10 (50.00%) 
Platlets  1  5/10 (50.00%) 
Cardiac disorders   
Hypotension  1  1/10 (10.00%) 
Gastrointestinal disorders   
Constipation  1  2/10 (20.00%) 
Diarrhea  1  1/10 (10.00%) 
Other GI  1  2/10 (20.00%) 
General disorders   
Fatigue  1  4/10 (40.00%) 
Fever  1  3/10 (30.00%) 
Rigors  1  2/10 (20.00%) 
Weight Loss  1  1/10 (10.00%) 
Dehydration  1  1/10 (10.00%) 
Distention  1  1/10 (10.00%) 
Dysgeusia  1  3/10 (30.00%) 
Nausea  1  6/10 (60.00%) 
Oral Mucositis  1  2/10 (20.00%) 
Vomiting  1  5/10 (50.00%) 
Dizziness  1  2/10 (20.00%) 
Sensory Neuropathy  1  2/10 (20.00%) 
Pain Abdominal, chest, back  1  3/10 (30.00%) 
Headache  1  1/10 (10.00%) 
COugh/Dyspnea  1  2/10 (20.00%) 
Infections and infestations   
Cellulitis  1  1/10 (10.00%) 
Metabolism and nutrition disorders   
Creatinine  1  1/10 (10.00%) 
Hyperbilirubinemia  1  1/10 (10.00%) 
Hypokalemia  1  1/10 (10.00%) 
Hypoantremia  1  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness/ Cramping  1  2/10 (20.00%) 
Psychiatric disorders   
Anoxeria  1  2/10 (20.00%) 
Skin and subcutaneous tissue disorders   
Pruritus  1  1/10 (10.00%) 
Other  1  1/10 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Setsuko K Chambers
Organization: University Of Arizona
Phone: 520/626-0950
EMail: schambers@azcc.arizona.edu
Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT00867503     History of Changes
Other Study ID Numbers: 08-1137-04
First Submitted: March 20, 2009
First Posted: March 23, 2009
Results First Submitted: October 1, 2012
Results First Posted: November 29, 2012
Last Update Posted: July 24, 2018