Trial Outcomes & Findings for Ixabepilone and Hydroxychloroquine in Treating Patients With Metastatic Breast Cancer (NCT NCT00765765)
NCT ID: NCT00765765
Last Updated: 2023-08-09
Results Overview
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.
TERMINATED
PHASE1/PHASE2
6 participants
3 years
2023-08-09
Participant Flow
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.
Participant milestones
| Measure |
Ixabepilone and Hydroxychloroquine
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 Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ixabepilone and Hydroxychloroquine in Treating Patients With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Ixabepilone and Hydroxychloroquine
n=6 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
51.7 years
STANDARD_DEVIATION 11.2 • n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPopulation: The study was closed early due to slow accrual. Insufficient data were collected to evaluate this outcome measure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: The study was closed early due to slow accrual. Insufficient data were collected to analyze this outcome measure.
Outcome measures
Outcome data not reported
Adverse Events
Ixabepilone and Hydroxychloroquine
Serious adverse events
| Measure |
Ixabepilone and Hydroxychloroquine
n=6 participants at risk
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.
|
|---|---|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
Other adverse events
| Measure |
Ixabepilone and Hydroxychloroquine
n=6 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
66.7%
4/6 • Number of events 15 • 1 year, 8 months
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
50.0%
3/6 • Number of events 7 • 1 year, 8 months
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
|
General disorders
Pain - Abdomen NOS
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
|
General disorders
Pain - Back
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
|
General disorders
Pain - Bone
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
|
General disorders
Pain - Chest wall
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
|
General disorders
Pain - Joint
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
|
General disorders
Pain - Muscle
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
33.3%
2/6 • Number of events 2 • 1 year, 8 months
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
33.3%
2/6 • Number of events 2 • 1 year, 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
33.3%
2/6 • Number of events 2 • 1 year, 8 months
|
|
Cardiac disorders
Cardiac General
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
|
Vascular disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
|
Psychiatric disorders
Mood alteration - Depression
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
|
Eye disorders
Vision-flashing lights/floaters
|
16.7%
1/6 • Number of events 1 • 1 year, 8 months
|
Additional Information
Dr. Vassiliki Karantza
Cancer Institute of New Jersey
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place