Patient Satisfaction, Efficacy and Compliance of Antiemetic Patch vs Pill in Malignant Glioma Patients

NCT01952886 | Withdrawn Phase 2 DMC

• 1 other identifier: Pro00041233
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess patient satisfaction, the efficacy and compliance of granisetron patch versus ondansetron pills for radiation induced nausea and vomiting in malignant glioma patients receiving six weeks of radiation therapy (RT) and concomitant temozolomide (TMZ). Use of the patch may benefit brain tumor patients by increasing compliance. All eligible adult malignant glioma subjects should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily TMZ for a total of six weeks. Subjects will be randomized to receive either granisetron patch or ondansetron for three weeks. Weeks 3-6, they will received the other medication. The granisetron transdermal delivery system (supplied as a 52 cm\^2 patch containing 34.3 mg of granisetron - 3.1 mg/day) is applied once per week 24 hours before the weekly radiation and chemotherapy, while the ondansetron 8 mg oral tablet is taken once a day 30-60 minutes prior to each dose of chemotherapy. Subjects will fill out questionnaires regarding the effectiveness of the medication and their satisfaction, and which anti-emetic they prefer. Safety will be assessed throughout the six weeks of radiation by the clinical research nurse using the Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0. All subjects who receive both ondansetron and Granisetron Transdermal Delivery System (GTDS) treatment will be included in analyses of treatment preference. However, all other efficacy and safety analyses will include all subjects who received ondansetron or GTDS.

Conditions

Malignant Glioma

Keywords

malignant glioma; antiemetic; ondansetron; granisetron; Preston Robert Tisch Brain Tumor Center; Pro00041233; Duke

Outcome Measures

Primary Outcomes (1)

• Satisfaction with Granisetron Transdermal Delivery System (GTDS) versus Ondansetron pill

  The percentage of subjects who prefer GTDS over Ondansetron pills as determined by the response to the question "Which nausea medication was I most satisfied with?"

  first 2 weeks after starting study

Secondary Outcomes (4)

• Complete response (CR) rate of Granisetron Transdermal Delivery System (GTDS) compared to Ondansetron pill

  first 2 weeks after starting study

• Subject Compliance with Granisetron Transdermal Delivery System (GTDS) and Ondansetron pills

  2 weeks

• Number of subjects experiencing a grade ≥3 treatment-related toxicity

  2 weeks

• Patient satisfaction from the Treatment Satisfaction Questionnaire for Medication (TSQM-9 )

  2 weeks

Study Arms (2)

Granisetron patch

EXPERIMENTAL

Granisetron transdermal delivery system (supplied as a 52 cm\^2 patch containing 34.3 mg of granisetron - 3.1 mg/day) is applied once per week.

Drug: Granisetron

Ondansetron tablet

ACTIVE COMPARATOR

Ondansetron 8 mg oral tablet is prescribed for once a day.

Drug: Ondansetron

Interventions

Granisetron DRUG

Also known as: Kytril

Granisetron patch

Ondansetron DRUG

Also known as: Zofran, Zuplenz

Ondansetron tablet

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically confirmed diagnosis of malignant glioma (Glioblastoma, gliosarcoma or anaplastic astrocytoma, or anaplastic oligodendroglioma) who may or may not be chemotherapy naïve and who are scheduled to receive radiotherapy (for a total of 60 GY) and concomitant daily temozolomide therapy (at a dose of 75 mg/m2 for one complete six week cycle).
• Age ≥ 18 years
• Karnofsky ≥ 60%
• Hematocrit \> 29%, ANC \>1,000 cells/mm3, platelets \> 100,000 cells/ mm3
• Serum creatinine \< 1.4 mg/dl, serum SGOT and bilirubin \< 1.5 times upper limit of normal
• For patients on corticosteroids, they must have been on a stable dose for 1 week prior to entry, and the dose should not be escalated over entry dose level, if clinically possible
• Ability and willingness to give informed consent
• If sexually active, patients will take contraceptive measures for the duration of the treatments
• Negative serum pregnancy test 48 hours prior to beginning study drug

You may not qualify if:

• Pregnancy or breastfeeding
• Co-medication that may interfere with study results; e.g., immune-suppressive agents other than corticosteroids
• Inability or unwillingness to cooperate with the study procedures
• Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to the start of radiation therapy through the full course of radiation therapy is prohibited, with the exception of the study drug. Corticosteroids will be allowed for treatment of cerebral swelling. Rescue medication for treatment of nausea and vomiting is permitted after radiation therapy at the discretion of the investigator
• Previous participation in any clinical trial involving granisetron
• Any vomiting, retching, or NCI Common Toxicity Criteria version 4.0 grade 2-4 nausea in the 24 hours preceding radiation and chemotherapy
• Ongoing vomiting from any organic etiology
• Radiotherapy of abdomen within one week prior to or during the study
• Received granisetron within 14 days prior to study enrollment
• Prior and concomitant cancer chemotherapy and radiotherapy

Sponsors & Collaborators

• Duke University: lead
• Kyowa Kirin Co., Ltd.: collaborator

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location

Related Links

• The Preston Robert Tisch Brain Tumor Center at Duke

MeSH Terms

Conditions

Glioma

Interventions

Granisetron; Ondansetron

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Study Officials

• Mary Lou Affronti, DNP, MSN, MHSc

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: September 30, 2013
• Primary Completion: September 1, 2014
• Last Updated: September 22, 2014

Record last verified: 2014-09

Locations

US (1)