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

NCT00636805 | Terminated Phase 2 Results

• 2 other identifiers: Pro00002273P50NS020023
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

• 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.

Conditions

Brain Cancer

Keywords

Aloxi; Brain Neoplasm, Primary; Brain Neoplasms, Malignant

Outcome Measures

Primary Outcomes (1)

• 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.

  first 24 hours of the first week of chemotherapy

Secondary Outcomes (6)

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

  Day 1 of the first week of chemotherapy

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

  Day 1 of the first week of chemotherapy

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

  Days 2-5 of the first week of chemotherapy

• Percentage of Patients With ≥ Grade 3, Treatment-related Toxicities

  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

  Baseline through day 5 of the first week of chemotherapy

Study Arms (1)

1

EXPERIMENTAL

Patient receives IV Aloxi

Drug: Palonosetron (Aloxi) and Dexamethasone

Interventions

Palonosetron (Aloxi) and Dexamethasone DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Duke University: lead
• Eisai Inc.: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Palonosetron; Dexamethasone

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Mary Lou Affronti
• Organization: Duke University Medical Center

mary.affronti@dm.duke.edu

919-6846239

Study Officials

• Mary Lou Affronti, RN, MSN, ANP

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2008
• First Posted: March 14, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 1, 2014
• Results First Posted: April 1, 2014

Record last verified: 2014-03

Locations

US (1)