A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IV Trial of Cesamet™ Given With Standard Antiemetic Therapy for Chemotherapy-induced Nausea and Vomiting|
- To demonstrate incremental improvement with Cesamet in control of chemotherapy induced nausea and vomiting in patients who have failed to respond adequately to standard antiemetic regimens. [ Time Frame: unk ] [ Designated as safety issue: No ]
- To determine whether the addition of Cesamet to standard antiemetic regimens leads to incremental benefit in the secondary outcomes of: [ Time Frame: unk ] [ Designated as safety issue: No ]
- The percent of patients with no emetic episodes, the percentage of patients with no nausea, the percentage of patients with no significant nausea [ Time Frame: unk ] [ Designated as safety issue: No ]
- time to first emetic episode, decrease in pain over the 5 day study period, decrease in analgesic use over the 5 day study period,Improvement in global quality of life as compared to without cannabinoid use [ Time Frame: unk ] [ Designated as safety issue: No ]
- the mean (or median) change in VAS score for nausea and pain [ Time Frame: unk ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
|United States, Ohio|
|Columbus, Ohio, United States, 43215|
|Principal Investigator:||Ralph Boccia, M.D.||Center for Cancer and Blood Disorders|