Trial Outcomes & Findings for Aloxi for Prevention of Chemotherapy Induced Nausea and Vomiting in Malignant Glioma Patients Receiving Irinotecan With Bevacizumab (NCT NCT00636805)
NCT ID: NCT00636805
Last Updated: 2014-04-01
Results Overview
Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
first 24 hours of the first week of chemotherapy
Results posted on
2014-04-01
Participant Flow
Participant milestones
| Measure |
Patient Receives IV Aloxi
Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
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|---|---|
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Overall Study
STARTED
|
63
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aloxi for Prevention of Chemotherapy Induced Nausea and Vomiting in Malignant Glioma Patients Receiving Irinotecan With Bevacizumab
Baseline characteristics by cohort
| Measure |
Patient Receives IV Aloxi
n=63 Participants
Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
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|---|---|
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Age, Continuous
|
53.2 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
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21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: first 24 hours of the first week of chemotherapyPopulation: Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy
Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.
Outcome measures
| Measure |
Patient Receives IV Aloxi
n=52 Participants
Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
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|---|---|
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Acute CINV (Chemotherapy Induced Nausea and Vomiting) CR (Complete Response) Rate
|
62 percentage of participants
Interval 47.0 to 75.0
|
SECONDARY outcome
Timeframe: Day 1 of the first week of chemotherapyPopulation: Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy
Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.
Outcome measures
| Measure |
Patient Receives IV Aloxi
n=52 Participants
Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
|
|---|---|
|
Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Corticosteroid Use at Baseline
corticosteroid used at baseline
|
68 percentage of participants
Interval 43.0 to 87.0
|
|
Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Corticosteroid Use at Baseline
no corticosteroid used at baseline
|
58 percentage of participants
Interval 39.0 to 75.0
|
SECONDARY outcome
Timeframe: Day 1 of the first week of chemotherapyPopulation: Intent-to-treat; 11 patients did not complete the study measure for day 1 of the first week of chemotherapy
Acute Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.
Outcome measures
| Measure |
Patient Receives IV Aloxi
n=52 Participants
Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
|
|---|---|
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Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Anticoagulant Use at Baseline
anticoagulant used at baseline
|
61 percentage of participants
Interval 43.0 to 77.0
|
|
Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Anticoagulant Use at Baseline
no anticoagulant used at baseline
|
63 percentage of participants
Interval 35.0 to 85.0
|
SECONDARY outcome
Timeframe: Days 2-5 of the first week of chemotherapyPopulation: Intent-to-treat; 10 patients did not complete the study measure for days 2-5 of the first week of chemotherapy
Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) complete response (CR) rate is defined as the percentage of patients who do not have an emetic episode or use antiemetic rescue medication during days 2 through 5 of chemotherapy treatment during the first cycle of treatment
Outcome measures
| Measure |
Patient Receives IV Aloxi
n=53 Participants
Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
|
|---|---|
|
Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate
|
62 percentage of participants
Interval 48.0 to 75.0
|
SECONDARY outcome
Timeframe: 6 weeksPercentage of patients with ≥ grade 3, treatment-related toxicities using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Outcome measures
| Measure |
Patient Receives IV Aloxi
n=63 Participants
Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
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|---|---|
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Percentage of Patients With ≥ Grade 3, Treatment-related Toxicities
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline through day 5 of the first week of chemotherapyPopulation: Intent-to-treat; 16 patients did not complete the study measure at baseline or on day 5 of the first week of chemotherapy
Overall mean change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score from baseline to day 5 of the first week of chemotherapy. The FACIT-Fatigue is a 13-item validated questionnaire assessing the impact of fatigue on an individual's quality of life. The raw score range is 0-52 with higher scores indicating better quality of life. The mean change from baseline to day 5 was calculated by subtracting the baseline score from mean of the day 1-5 scores, thus a negative mean change represents worsening in quality of life due to fatigue.
Outcome measures
| Measure |
Patient Receives IV Aloxi
n=47 Participants
Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
|
|---|---|
|
Overall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to Day 5 of the First Week of Chemotherapy
|
-3.5 units on a scale
Interval -6.1 to -0.9
|
SECONDARY outcome
Timeframe: Baseline through day 5 of the first week of chemotherapyPopulation: Intent-to-treat; 16 patients did not complete the study measure at baseline or on day 5 of the first week of chemotherapy
Overall mean change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score from baseline to day 5 of the first week of chemotherapy. The FACIT-Fatigue is a 13-item validated questionnaire assessing the impact of fatigue on an individual's quality of life. The raw score range is 0-52 with higher scores indicating better quality of life. The mean change from baseline to day 5 was calculated by subtracting the baseline score from the mean of the day 1-5 scores, thus a negative mean change represents worsening in quality of life due to fatigue. Acute CINV complete response (CR) is defined as not having an emetic episode or any use of antiemetic rescue medication during the first 24 hours following chemotherapy of the first cycle of treatment.
Outcome measures
| Measure |
Patient Receives IV Aloxi
n=47 Participants
Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
|
|---|---|
|
Overall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to Day 5 of the First Week of Chemotherapy by Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR)
CR
|
-3.5 units on a scale
Interval -6.4 to -0.6
|
|
Overall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to Day 5 of the First Week of Chemotherapy by Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR)
Not CR
|
-3.3 units on a scale
Interval -8.8 to 2.2
|
Adverse Events
Patient Receives IV Aloxi
Serious events: 3 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patient Receives IV Aloxi
n=63 participants at risk
Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
|
|---|---|
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Investigations
White blood cell decreased
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
General disorders
Fatigue
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Gastrointestinal disorders
Diarrhea
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Infections and infestations
Infection - Other (Specify, CSF)
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Infections and infestations
Infections and infestations
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Infections and infestations
Lung infection
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Vascular disorders
Thromboembolic event
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
Other adverse events
| Measure |
Patient Receives IV Aloxi
n=63 participants at risk
Patient receives IV Aloxi
Palonosetron (Aloxi) and Dexamethasone: single i.v. , dose of palonosetron 0.25 mg, and 10mg dexamethasone infused over 15 min, administered 30 min before the first dose Irinotecan and Bevacizumab chemotherapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Investigations
White blood cell decreased
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Investigations
Neutrophil count decreased
|
4.8%
3/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
General disorders
Fatigue
|
31.7%
20/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Psychiatric disorders
Insomnia
|
28.6%
18/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Investigations
Weight loss
|
11.1%
7/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Injury, poisoning and procedural complications
Burn
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.3%
4/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.8%
3/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Metabolism and nutrition disorders
Anorexia
|
17.5%
11/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Gastrointestinal disorders
Constipation
|
25.4%
16/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Gastrointestinal disorders
Diarrhea
|
31.7%
20/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Gastrointestinal disorders
Gastritis
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Gastrointestinal disorders
Hemorrhoids
|
3.2%
2/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Gastrointestinal disorders
Mucositis
|
15.9%
10/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Gastrointestinal disorders
Mucositis oral
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Gastrointestinal disorders
Nausea
|
38.1%
24/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Gastrointestinal disorders
Esophageal ulcer
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Gastrointestinal disorders
Vomiting
|
15.9%
10/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
11.1%
7/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Infections and infestations
Bladder infection
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Infections and infestations
pneumonia
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Renal and urinary disorders
Proteinuria
|
1.6%
1/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Nervous system disorders
Ataxia
|
23.8%
15/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Nervous system disorders
Cognitive disturbance
|
30.2%
19/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Nervous system disorders
Confusion
|
28.6%
18/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Nervous system disorders
Dizziness
|
20.6%
13/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Nervous system disorders
Memory impairment
|
25.4%
16/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Nervous system disorders
Mood alteration
|
25.4%
16/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
30.2%
19/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.5%
6/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Nervous system disorders
Seizure
|
15.9%
10/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Nervous system disorders
Depressed level of consciousness
|
36.5%
23/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Nervous system disorders
Dysphasia
|
14.3%
9/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Nervous system disorders
Tremor
|
17.5%
11/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Eye disorders
Blurred vision
|
19.0%
12/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Nervous system disorders
Headache
|
20.6%
13/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.7%
8/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.2%
2/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other, specify
|
15.9%
10/63 • 6 weeks
The adverse events for this study were collected using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
|
Additional Information
Results disclosure agreements
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Restriction type: OTHER