Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00418678
Status:
TERMINATED
Last Update Posted:
2010-12-02
First Post:
2007-01-03
Brief Title:
A Phase IV Trial of Cesamet Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting
Sponsor:
Veeda Oncology
Organization:
Veeda Oncology
Study Overview
Official Title:
A Phase IV Trial of Cesamet Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting
Status:
TERMINATED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollment was too slow
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase IV open-label sequential treatment study in patients who are receiving standard chemotherapy for non-small cell lung cancer breast cancer or colorectal cancer See Section 421 for eligible treatment regimens The study will take place during the first 2 cycles of chemotherapy
Phase 1 of study
Prior to the first dose of chemotherapy patients will be instructed on how to complete their patient diary which will include a Visual Analogue Scale VAS for nausea and a VAS for pain In addition the diary will include a section to list their current pain medications see Sample Patient Diary in Appendix I After being instructed patients will complete the VAS for nausea and for pain as well as listing their current pain medications Patients will then receive chemotherapy on Day 1 of Cycle 1 in combination with the pre-defined standard serotonin antagonistcorticosteroid regimen
Beginning on Day 2 the diary will be completed for 5 consecutive days Days 2-6 Each day patients will complete a diary entry pertaining to the preceding 24 hours The entry will include the number and time of any emetic episodes any antiemetic rescue medications used VAS for nausea and side effects of treatment On the last day of the diary Day 6 the entry will include the above daily parameters but will also include a VAS for pain In addition the patient will complete a diary entry pertaining to the 5-day study period that will include pain medications used Patients will also complete the Functional Living Index - Cancer FLIC questionnaire see Sample Function Living Index - Cancer questionnaire in Appendix II
Patients who either have at least one vomiting episode or at least one report of significant nausea VAS 25 mm during the first 5-day study period will be eligible for the second phase of the study
Phase 2 of the study
Patients in the second phase will receive a second cycle of the same chemotherapy The antiemetic regimen for the second cycle will be the same serotonin antagonistcorticosteroid regimen as they received in Cycle 1 with the addition of Cesamet
For Cycle 2 of treatment patients will receive Cesamet 1 mg the night before chemotherapy is to be administered On the day of chemotherapy Day 1 of Cycle 2 Cesamet 2 mg will be given 1 to 3 hours before the chemotherapy is administered in addition to the same serotonin antagonistcorticosteroid regimen as they received in Cycle 1 Patients will receive an additional dose of Cesamet 2 mg the evening of Day 1
Patients will receive Cesamet 2 mg BID on Days 2-5 Patients will complete the same 5-day diary and FLIC questionnaire as they did in Cycle 1 Beneficial effects of Cesamet will be estimated by comparing the results of the second cycle to the results of the first cycle
Patients will be evaluated for the first 2 cycles of chemotherapy only
Phase 1 of study
Prior to the first dose of chemotherapy patients will be instructed on how to complete their patient diary which will include a Visual Analogue Scale VAS for nausea and a VAS for pain In addition the diary will include a section to list their current pain medications see Sample Patient Diary in Appendix I After being instructed patients will complete the VAS for nausea and for pain as well as listing their current pain medications Patients will then receive chemotherapy on Day 1 of Cycle 1 in combination with the pre-defined standard serotonin antagonistcorticosteroid regimen
Beginning on Day 2 the diary will be completed for 5 consecutive days Days 2-6 Each day patients will complete a diary entry pertaining to the preceding 24 hours The entry will include the number and time of any emetic episodes any antiemetic rescue medications used VAS for nausea and side effects of treatment On the last day of the diary Day 6 the entry will include the above daily parameters but will also include a VAS for pain In addition the patient will complete a diary entry pertaining to the 5-day study period that will include pain medications used Patients will also complete the Functional Living Index - Cancer FLIC questionnaire see Sample Function Living Index - Cancer questionnaire in Appendix II
Patients who either have at least one vomiting episode or at least one report of significant nausea VAS 25 mm during the first 5-day study period will be eligible for the second phase of the study
Phase 2 of the study
Patients in the second phase will receive a second cycle of the same chemotherapy The antiemetic regimen for the second cycle will be the same serotonin antagonistcorticosteroid regimen as they received in Cycle 1 with the addition of Cesamet
For Cycle 2 of treatment patients will receive Cesamet 1 mg the night before chemotherapy is to be administered On the day of chemotherapy Day 1 of Cycle 2 Cesamet 2 mg will be given 1 to 3 hours before the chemotherapy is administered in addition to the same serotonin antagonistcorticosteroid regimen as they received in Cycle 1 Patients will receive an additional dose of Cesamet 2 mg the evening of Day 1
Patients will receive Cesamet 2 mg BID on Days 2-5 Patients will complete the same 5-day diary and FLIC questionnaire as they did in Cycle 1 Beneficial effects of Cesamet will be estimated by comparing the results of the second cycle to the results of the first cycle
Patients will be evaluated for the first 2 cycles of chemotherapy only
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None