A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting
Status:
Terminated
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
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 4.2.1 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 antagonist/corticosteroid 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 antagonist/corticosteroid
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
antagonist/corticosteroid 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:
Phase 4
Details
Lead Sponsor:
Veeda Oncology
Collaborators:
Bausch Health Americas, Inc. Valeant Pharmaceuticals International, Inc.