TerminatedNCT00636805Updated Apr 1, 2014Results posted

Aloxi for Prevention of Chemotherapy Induced Nausea and Vomiting in Malignant Glioma Patients Receiving Irinotecan With Bevacizumab

A Phase 2 interventional study of Palonosetron (Aloxi) and Dexamethasone in Brain Cancer, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-01.

Sponsored by Duke University · Phase 2, Interventional, and Supportive care

Why this study was terminated

Study was halted early after 63 subjects were enrolled due to slow accrual.

Phase: Phase 2
Study type: Interventional
Enrollment: 63
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

Primary Objective:
- To determine the efficacy and tolerability of palonosetron and dexamethasone in preventing acute CINV in brain tumor patients during the first 24 hours of receiving Irinotecan /Bevacizumab regimens.
Secondary Objective
- To determine the safety and tolerability of palonosetron in brain tumor patients.
- To determine the effects of glucocorticoid and anticonvulsants on the efficacy of palonosetron.
- To determine the efficacy of palonosetron and dexamethasone in preventing delayed CINV in brain tumor patients during days 2-5.
- To determine if patients receiving palonosetron have less fatigue than baseline.

Read the detailed description

Before the patients receive the palonosetron, a physical exam and blood tests are performed to determine eligibility. If eligible and willing, subjects are given Palonosetron intravenously. Subjects are given the Palonosetron and Dexamethasone 30 minutes before the first dose of Irinotecan and Bevacizumab chemotherapy. The total expected duration of participation is 57 days. Subjects are also asked to complete 4 questionnaires about nausea and vomiting, as well as daily functioning and fatigue. Subjects are asked to complete these questionnaires before starting chemotherapy, the day of starting chemotherapy and for the next 4 days after receiving chemotherapy, for a total of 6 times. Subjects are asked to complete this set of questionnaires each of the 3 times that they receive chemotherapy during the 6-week treatment cycle.

The other treatments subjects would normally receive for their brain tumor and their routine care are not affected by the study.

Conditions studied

Brain Cancer

Browse trials for

Brain Neoplasms 1,993

Keywords

Aloxi
Brain Neoplasm, Primary
Brain Neoplasms, Malignant

In context

Brain Neoplasms

1,993 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's enrollment of 63 is above the median of 40 across 1,479 interventional studies indexed under Brain Neoplasms.

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Lead sponsor

Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

In order to be included in the study, patients must meet all of the following criteria:

Patients must have histologically confirmed diagnosis of primary malignant glioma (glioblastoma multiforme, gliosarcoma or anaplastic astrocytoma, or anaplastic oligodendroglioma) who are either chemotherapy naïve or non-naïve and scheduled to receive Irinotecan/Bevacizumab chemotherapy.
Patients with recurrent disease whose diagnostic pathology confirmed malignant glioma (glioblastoma multiforme, gliosarcoma or anaplastic astrocytoma, or anaplastic oligodendroglioma) will not need re-biopsy.
Age > or = 18 years.
Patient is scheduled to receive Irinotecan/Bevacizumab chemotherapy every 2 weeks for one complete 6-week cycle.
An interval of at least 6 weeks between prior surgical resection and study enrollment.
An interval of at least 4 weeks between prior radiotherapy and enrollment on this protocol unless there is unequivocal evidence of tumor progression after radiotherapy or chemotherapy.
The lab values following the prior chemotherapy must return within normal limits prior to study enrollment.
Karnofsky > 60%.
Hematocrit > 29%, absolute neutrophil count (ANC) > 1,500 cells/*l, platelets > 125,000 cells/*l.
Serum creatinine \< 1.5 mg/dl, serum glutamic-oxaloacetic transaminase (SGOT) and bilirubin \< 1.5 times upper limit of normal.
Patients on corticosteroids must be on a stable dose for 1 week prior to entry, and the dose should not be escalated over entry dose level, if clinically possible.
Signed consent form approved by the Institutional Review Board prior to patient entry.
No evidence of hemorrhage on the baseline MRI or CT scan.
If sexually active, patients will take contraceptive measures for the duration of the treatments.

Exclusion criteria

Exclusion Criteria:

Patients are excluded from this study if they meet any of the following criteria:

Inability or unwillingness to understand or cooperate with study procedures.
Received any intravenous drug with potential anti-emetic effect within 24 hours prior to the start of study-designated chemotherapeutic agent or be scheduled to receive any drug of this type (with the exception of administration of the palonosetron/dexamethasone infusion solution) at any time during the trial, including the following:
5 HT3 receptor antagonists;
Dopamine receptor antagonists (metoclopramide);
Phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine);
Diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide. Diphenhydramine will be allowed if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes;
Haloperidol, droperidol, tetrahydrocannabinol, or nabilone; and
Any systemic corticosteroid (hydrocortisone, methylprednisolone, prednisone). Topical or inhaled preparations are allowed;
Previous participation in any clinical trial involving palonosetron (RS-25259 of Syntex).
Any vomiting, retching or NCI Common Toxicity Criteria version 3.0 grade 2-4 nausea (see Appendix 8.6) in the 24 hours preceding chemotherapy.
Ongoing vomiting from any organic etiology.
Will receive radiotherapy of upper abdomen or cranium within one week prior to or during the study.
Received palonosetron within 14 days prior to study enrollment (AloxiTM).
Evidence of central nervous system (CNS) hemorrhage on baseline MRI on CT scan.
Co -medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids.
Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to the start of chemotherapy through 120 hours after the initiation of chemotherapy on Study Day 1 (Study Day 6) is prohibited, with the exception of the study drug. Corticosteroids will be allowed for treatment of cerebral swelling. Diphenhydramine will be allowed only if given for prophylactic treatment of hypersensitivity reactions associated with the administration of taxanes, as per the package insert for these agents. Rescue medication for treatment of nausea and vomiting is permitted after chemotherapy at the discretion of the investigator. The agent, dose, and time of administration will be recorded in the patient diary.

Study design

Phase: Phase 2
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 63 participants (actual)

Study arms

Experimental
1
Patient receives IV Aloxi
Drug: Palonosetron (Aloxi) and Dexamethasone

Interventions

DrugPalonosetron (Aloxi) and Dexamethasone
Drug page: Palonosetron
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.
Also known as: Aloxi

What researchers measure

Primary outcomes

Acute CINV (Chemotherapy Induced Nausea and Vomiting) CR (Complete Response) Rate
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.
Time frame: first 24 hours of the first week of chemotherapy

Secondary outcomes

Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Corticosteroid Use at Baseline
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.
Time frame: Day 1 of the first week of chemotherapy
Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Anticoagulant Use at Baseline
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.
Time frame: Day 1 of the first week of chemotherapy
Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate
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
Time frame: Days 2-5 of the first week of chemotherapy
Percentage of Patients With ≥ Grade 3, Treatment-related Toxicities
Percentage of patients with ≥ grade 3, treatment-related toxicities using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time frame: 6 weeks
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
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.
Time frame: Baseline through 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 by Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR)
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.
Time frame: Baseline through day 5 of the first week of chemotherapy

Results

Posted Apr 1, 2014

Participant flow

Participant flow — Overall Study
Milestone	Patient Receives IV Aloxi
Started	63
Completed	63
Not completed	0

Outcome measures

PrimaryAcute CINV (Chemotherapy Induced Nausea and Vomiting) CR (Complete Response) Rate

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.

Time frame:: first 24 hours of the first week of chemotherapy
Reported as:: Number · percentage of participants

Acute CINV (Chemotherapy Induced Nausea and Vomiting) CR (Complete Response) Rate
percentage of participants	Patient Receives IV Aloxi
Acute CINV (Chemotherapy Induced Nausea and Vomiting) CR (Complete Response) Rate	62 (47 to 75)

SecondaryAcute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Corticosteroid Use at Baseline

Time frame:: Day 1 of the first week of chemotherapy
Reported as:: Number · percentage of participants

Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Corticosteroid Use at Baseline
percentage of participants	Patient Receives IV Aloxi
corticosteroid used at baseline	68 (43 to 87)
no corticosteroid used at baseline	58 (39 to 75)

SecondaryAcute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Anticoagulant Use at Baseline

Time frame:: Day 1 of the first week of chemotherapy
Reported as:: Number · percentage of participants

Acute Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate by Anticoagulant Use at Baseline
percentage of participants	Patient Receives IV Aloxi
anticoagulant used at baseline	61 (43 to 77)
no anticoagulant used at baseline	63 (35 to 85)

SecondaryDelayed Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate

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

Time frame:: Days 2-5 of the first week of chemotherapy
Reported as:: Number · percentage of participants

Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate
percentage of participants	Patient Receives IV Aloxi
Delayed Chemotherapy-Induced Nausea and Vomiting (CINV) Complete Response (CR) Rate	62 (48 to 75)

SecondaryPercentage of Patients With ≥ Grade 3, Treatment-related Toxicities

Percentage of patients with ≥ grade 3, treatment-related toxicities using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

Time frame:: 6 weeks
Reported as:: Number · participants

Percentage of Patients With ≥ Grade 3, Treatment-related Toxicities
participants	Patient Receives IV Aloxi
Percentage of Patients With ≥ Grade 3, Treatment-related Toxicities	0

SecondaryOverall Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline to 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.

Time frame:: Baseline through day 5 of the first week of chemotherapy
Reported as:: Mean · units on a scale

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
units on a scale	Patient Receives IV Aloxi
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 (-6.1 to -0.9)

SecondaryOverall 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)

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.

Time frame:: Baseline through day 5 of the first week of chemotherapy
Reported as:: Mean · units on a scale

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)
units on a scale	Patient Receives IV Aloxi
CR	-3.5 (-6.4 to -0.6)
Not CR	-3.3 (-8.8 to 2.2)

Adverse events

Collected over 6 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Patient Receives IV Aloxi	—	3/63 (4.8%)	51/63 (81%)

Most frequent serious events

Most frequent serious events
Event	Patient Receives IV Aloxi
White blood cell decreasedInvestigations	1/63
FatigueGeneral disorders	1/63
DiarrheaGastrointestinal disorders	1/63
NauseaGastrointestinal disorders	1/63
Infection - Other (Specify, CSF)Infections and infestations	1/63
Infections and infestationsInfections and infestations	1/63
Lung infectionInfections and infestations	1/63
Adult respiratory distress syndromeRespiratory, thoracic and mediastinal disorders	1/63
Thromboembolic eventVascular disorders	1/63

Most frequent other events

Showing 10 of 42

Most frequent other events
Event	Patient Receives IV Aloxi
NauseaGastrointestinal disorders	24/63
Depressed level of consciousnessNervous system disorders	23/63
FatigueGeneral disorders	20/63
DiarrheaGastrointestinal disorders	20/63
Cognitive disturbanceNervous system disorders	19/63
Peripheral motor neuropathyNervous system disorders	19/63
InsomniaPsychiatric disorders	18/63
ConfusionNervous system disorders	18/63
ConstipationGastrointestinal disorders	16/63
Memory impairmentNervous system disorders	16/63

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Patient Receives IV Aloxi
Mean	53.2 ± 13.1

Sex: Female, Male
Sex: Female, Male(Participants)	Patient Receives IV Aloxi
Female	21
Male	42

Study locations

1 site

Duke University Medical Center
Durham, North Carolina 27710, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2008, a primary completion of Jan 2013 and a completion of Jan 2013. It does not say whether these dates are actual or estimated.

Results were first posted in Apr 2014, 1 year 3 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 27, 2008
First posted: Mar 14, 2008
Start: May 2008
Primary completionActual: Jan 2013
CompletionActual: Jan 2013
Results first posted: Apr 1, 2014
Last update: Apr 1, 2014

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00636805
Lead sponsor: Duke University
Collaborators: Eisai Inc., National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party: Sponsor
First posted: Mar 14, 2008
Start date: May 2008
Primary completion: Jan 2013
Completion: Jan 2013
Results posted: Apr 1, 2014
Last update: Apr 1, 2014

Study contacts

Mary Lou Affronti, RN, MSN, ANP

principal investigator · Duke University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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