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Ixabepilone and Hydroxychloroquine in Treating Patients With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00765765
Recruitment Status : Terminated (Slow accrual)
First Posted : October 3, 2008
Results First Posted : December 25, 2013
Last Update Posted : December 25, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: hydroxychloroquine
Drug: ixabepilone
Enrollment 6
Recruitment Details Six subjects were recruited from The Cancer Institute of New Jersey (a comprehensive cancer center) and one of its affiliate community hospitals in New Jersey, from April 2009 through June 2010.
Pre-assignment Details  
Arm/Group Title Ixabepilone and Hydroxychloroquine
Hide Arm/Group Description

ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.

hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid.

Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Ixabepilone and Hydroxychloroquine
Hide Arm/Group Description

ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.

hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid.

Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
51.7  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
6
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Tumor Response Rate
Hide Description Overall Complete Response and Partial Response will be considered tumor response. Ixabepilone as a single agent (40 mg/m2 as an intravenous infusion every 3 weeks) was evaluated in a previous (Phase II) study in women with metastatic breast cancer and that the objective tumor response rate was 11.5%. In another(Phase III) study, Ixabepilone in combination with capecitabine resulted in an objective tumor response rate of 35%, compared to that of capecitabine alone (14%). Therefore, in the Phase II portion of the ixabepilone plus hydroxychloroquine combination treatment study, a tumor response rate of less than 15% will be deemed uninteresting. The target tumor response rate will be 35%. Due to uncertainty about the true response rate of ixabepilone plus hydroxychloroquine combination on this patient poupation, we also will consider a response rate of 30% to be encouraging.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to slow accrual. Insufficient data were collected to evaluate this outcome measure.
Arm/Group Title Ixabepilone and Hydroxychloroquine
Hide Arm/Group Description:

ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.

hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Duration of Response
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.
Arm/Group Title Ixabepilone and Hydroxychloroquine
Hide Arm/Group Description:

ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.

hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Time to Progressive Disease
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.
Arm/Group Title Ixabepilone and Hydroxychloroquine
Hide Arm/Group Description:

ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.

hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Survival Time
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.
Arm/Group Title Ixabepilone and Hydroxychloroquine
Hide Arm/Group Description:

ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.

hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Pharmacodynamic Markers for Autophagy Detection
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.
Arm/Group Title Ixabepilone and Hydroxychloroquine
Hide Arm/Group Description:

ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.

hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Effects of Hydroxychloroquine on Autophagy
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.
Arm/Group Title Ixabepilone and Hydroxychloroquine
Hide Arm/Group Description:

ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.

hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Correlation of Estrogen Receptor, Progesterone Receptor and/or HER2 Status With Treatment Response
Hide Description [Not Specified]
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.
Arm/Group Title Ixabepilone and Hydroxychloroquine
Hide Arm/Group Description:

ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.

hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year, 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ixabepilone and Hydroxychloroquine
Hide Arm/Group Description

ixabepilone : Starting dose of 40 mg/m2 and can dose reduce to 32 mg/m2.

hydroxychloroquine : Dose escalation from 200 mg po qd to 200 mg po bid.

All-Cause Mortality
Ixabepilone and Hydroxychloroquine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ixabepilone and Hydroxychloroquine
Affected / at Risk (%) # Events
Total   1/6 (16.67%)    
Cardiac disorders   
Pericardial effusion (non-malignant) * 1  1/6 (16.67%)  1
*
Indicates events were collected by non-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%
Ixabepilone and Hydroxychloroquine
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Blood and lymphatic system disorders   
Leukocytes (total WBC) * 1  4/6 (66.67%)  15
Neutrophils/granulocytes (ANC/AGC) * 1  3/6 (50.00%)  7
Blood/Bone Marrow - Other (Specify, __) * 1  1/6 (16.67%)  1
Hemoglobin * 1  1/6 (16.67%)  1
Cardiac disorders   
Cardiac General - Other (Specify, __) * 1  1/6 (16.67%)  1
Eye disorders   
Vision-flashing lights/floaters * 1  1/6 (16.67%)  1
General disorders   
Pain - Abdomen NOS * 1  1/6 (16.67%)  1
Pain - Back * 1  1/6 (16.67%)  1
Pain - Bone * 1  1/6 (16.67%)  1
Pain - Chest wall * 1  1/6 (16.67%)  1
Pain - Joint * 1  1/6 (16.67%)  1
Pain - Muscle * 1  1/6 (16.67%)  1
Pain - Other (Specify, __) * 1  1/6 (16.67%)  1
Fatigue (asthenia, lethargy, malaise) * 1  2/6 (33.33%)  2
Psychiatric disorders   
Mood alteration - Depression * 1  1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath) * 1  2/6 (33.33%)  2
Skin and subcutaneous tissue disorders   
Hair loss/alopecia (scalp or body) * 1  2/6 (33.33%)  2
Vascular disorders   
Hemorrhage, pulmonary/upper respiratory - Nose * 1  1/6 (16.67%)  1
*
Indicates events were collected by non-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: Dr. Vassiliki Karantza
Organization: Cancer Institute of New Jersey
Phone: 732-235-8675
EMail: karantva@cinj.rutgers.edu; rizzoji@cinj.rutgers.edu; zelinsta@cinj.rutgers.edu
Layout table for additonal information
Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00765765     History of Changes
Other Study ID Numbers: CDR0000615000
P30CA072720 ( U.S. NIH Grant/Contract )
CINJ-040804 ( Other Identifier: CINJ )
0220080205 ( Other Identifier: Rutgers University IRB )
First Submitted: October 2, 2008
First Posted: October 3, 2008
Results First Submitted: November 6, 2013
Results First Posted: December 25, 2013
Last Update Posted: December 25, 2013