Trial Outcomes & Findings for Ixabepilone and Liposomal Doxorubicin in Advanced Ovarian Cancer (NCT NCT00182767)
NCT ID: NCT00182767
Last Updated: 2016-03-10
Results Overview
Dose-Limiting Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events classification and usually encompasses all grade 3 or higher toxicities
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
28 days
Results posted on
2016-03-10
Participant Flow
A total of 45 patients were enrolled and treated between January 2006 and May 2011
Participant milestones
| Measure |
Ixabepilone: 24mg/m2 and Doxil 30 mg/m2: Level 1
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone: 32mg/m2 and Doxil 30 mg/m2: Level 2
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone: 40mg/m2 and Doxil 30 mg/m2: Level 3
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone: 13mg/m2 and Doxil 30 mg/m2: Level 4
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone: 16mg/m2 and Doxil 30 mg/m2: Level 5
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
3
|
24
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
3
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ixabepilone and Liposomal Doxorubicin in Advanced Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Ixabepilone and Doxorubicin)
n=45 Participants
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysDose-Limiting Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events classification and usually encompasses all grade 3 or higher toxicities
Outcome measures
| Measure |
Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1
n=6 Participants
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2
n=6 Participants
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3
n=6 Participants
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4
n=3 Participants
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5
n=9 Participants
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
|---|---|---|---|---|---|
|
Incidence of Dose-limiting Toxicity (DLT), Graded Using the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 4.0 (Phase I)
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Once 2 DLT events occur in patients during the first 28 days of treatment (cycle 1), the preceding dose will be designated the maximum tolerated dose (MTD).Population: The phase I component of the study included 30 patients with breast and ovarian cancer.
The phase I component of the study included 30 patients with breast and ovarian cancer. A protocol amendment was made during phase I trial from a treatment regimen of Schedule A (ixabepilone every 3-4 weeks) to Schedule B (ixabepilone every week). The maximum tolerated dose was determined to be the preceding dose of any dose that resulted in 2 DLT events. Schedule B was carried forward to the phase II trial. The Maximum Tolerated Dose for Schedule B is reported. Please see (Chuang et al., 2010) for additional details
Outcome measures
| Measure |
Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1
n=30 Participants
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
|---|---|---|---|---|---|
|
Maximum Tolerated Dose
|
16 mg/m2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 2 yearsOutcome measures
| Measure |
Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1
n=45 Participants
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
|---|---|---|---|---|---|
|
Proportion of Patients Responding to Therapy (Complete Response [CR], Partial Response [PR], or Stable Disease [SD]), Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) and Cancer Antigen-125 (CA-125) Response Criteria (Phase II)
Ovarian Cancer
|
20 participants
|
—
|
—
|
—
|
—
|
|
Proportion of Patients Responding to Therapy (Complete Response [CR], Partial Response [PR], or Stable Disease [SD]), Assessed According to Response Evaluation Criteria in Solid Tumors (RECIST) and Cancer Antigen-125 (CA-125) Response Criteria (Phase II)
Breast Cancer
|
7 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: The time from start of treatment to time of progression or death, assessed up to 2 yearsWe will summarize progression-free survival by Kaplan-Meier survival analysis.
Outcome measures
| Measure |
Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1
n=45 Participants
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
|---|---|---|---|---|---|
|
Progression-free Survival
|
4.1 months
Interval 2.7 to 8.2
|
—
|
—
|
—
|
—
|
Adverse Events
Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5
Serious events: 24 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1
n=6 participants at risk
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2
n=6 participants at risk
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3
n=6 participants at risk
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4
n=3 participants at risk
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5
n=24 participants at risk
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
|---|---|---|---|---|---|
|
Investigations
Blood Bilirubin increased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
General disorders
Fatigue
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
4/24 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Infections and infestations
Infection with grade 3 or 4 neutrophils
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Investigations
White blood cell count decreased
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Nervous system disorders
Neuropathy: Sensory
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Investigations
Neutrophils count decreased
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
20.8%
5/24 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash: desquamation
|
0.00%
0/6
|
0.00%
0/6
|
50.0%
3/6 • Number of events 3
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Infections and infestations
Lung infections
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
General disorders
Death NOS
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Chest Wall Pain
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
8.3%
2/24 • Number of events 2
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/24
|
|
Investigations
Platelet count decreased
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
Other adverse events
| Measure |
Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1
n=6 participants at risk
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2
n=6 participants at risk
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3
n=6 participants at risk
Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4
n=3 participants at risk
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5
n=24 participants at risk
Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1
ixabepilone: Given IV
pegylated liposomal doxorubicin hydrochloride: Given IV
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
25.0%
6/24 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Reproductive system and breast disorders
Breast pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
45.8%
11/24 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
16.7%
4/24 • Number of events 4
|
|
Gastrointestinal disorders
Anorexia
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
29.2%
7/24 • Number of events 7
|
|
Infections and infestations
Rash maculo-papular
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
66.7%
2/3 • Number of events 2
|
25.0%
6/24 • Number of events 6
|
|
Infections and infestations
Soft tissue infection
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
16.7%
4/24 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
12.5%
3/24 • Number of events 3
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
12.5%
3/24 • Number of events 3
|
|
Nervous system disorders
Peripheral motor neuropathy
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Eye disorders
Blurred vision
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
16.7%
4/24 • Number of events 4
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 3
|
50.0%
3/6 • Number of events 3
|
0.00%
0/6
|
100.0%
3/3 • Number of events 3
|
62.5%
15/24 • Number of events 15
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
25.0%
6/24 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Ascites
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/24
|
|
General disorders
Fever
|
0.00%
0/6
|
50.0%
3/6 • Number of events 3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
25.0%
6/24 • Number of events 6
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Investigations
Creatinine increased
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
33.3%
1/3 • Number of events 1
|
41.7%
10/24 • Number of events 10
|
|
General disorders
Chills
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
General disorders
Edema limbs
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
25.0%
6/24 • Number of events 6
|
|
Psychiatric disorders
Depression
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
4.2%
1/24 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Eye disorders
Dry eye
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
33.3%
1/3 • Number of events 1
|
29.2%
7/24 • Number of events 7
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
0.00%
0/24
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
66.7%
2/3 • Number of events 2
|
29.2%
7/24 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Hand and foot syndrome
|
0.00%
0/6
|
0.00%
0/6
|
66.7%
4/6 • Number of events 4
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
66.7%
2/3 • Number of events 2
|
37.5%
9/24 • Number of events 9
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/6
|
0.00%
0/6
|
50.0%
3/6 • Number of events 3
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
33.3%
1/3 • Number of events 1
|
20.8%
5/24 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/24
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
12.5%
3/24 • Number of events 3
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/24
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
4.2%
1/24 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/24
|
|
Infections and infestations
skin infection
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
0.00%
0/3
|
0.00%
0/24
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/24
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/24
|
|
Infections and infestations
Nail infection
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
0.00%
0/24
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/3
|
12.5%
3/24 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
66.7%
2/3 • Number of events 2
|
20.8%
5/24 • Number of events 5
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/24
|
|
Hepatobiliary disorders
Hepatic Pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/24
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/24
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
25.0%
6/24 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
33.3%
1/3 • Number of events 1
|
0.00%
0/24
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
16.7%
4/24 • Number of events 4
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
General disorders
Gait disturbance
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash: acneiform
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
12.5%
3/24 • Number of events 3
|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/3
|
8.3%
2/24 • Number of events 2
|
Additional Information
Lisa Escobar-Peralta, Program Manager
Montefiore Medical Center
Phone: 718-379-6866
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60