Status:
COMPLETED
Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting
Lead Sponsor:
Solvay Pharmaceuticals
Conditions:
Chemotherapy Induced Nausea and Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of the study is to determine the efficacy of oral dronabinol versus standard ondansetron antiemetic therapy in preventing delayed-onset chemotherapy-induced nausea and vomiting (CI...
Eligibility Criteria
Inclusion
- Histological evidence of non-CNS malignancy (primary or metastatic disease) and lymphomas which are not involving the bone marrow.
- Undergoing single or multiple days of chemotherapy as long as Day 1 chemotherapy includes:
- a moderate-to-high emetogenic regimen, or
- oxaliplatin at doses employed for treatment of colon cancer, or
- the combination of AC \[AdriamycinÒ (60 mg/m2) with cyclophosphamide (600 mg/m2)\] as to be used for the chemotherapeutic drug regimen involving taxanes in the treatment of breast cancer.
Exclusion
- Chemotherapy agents falling into the low (Level 1), moderate-to-low (Level 2), moderate (Level 3) unless used in combination with a Level 4 chemotherapy agent on Day 1 of the study.
- Chemotherapy agents falling into the high (Level 5) classification during study.
- Any combination of chemotherapy agents that does not fall into the moderate-to-high (Level 4) classification
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00642512
Start Date
July 1 2003
End Date
July 1 2004
Last Update
April 3 2008
Active Locations (43)
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1
Site 970
Tucson, Arizona, United States
2
Site 950
Anaheim, California, United States
3
Site 925
Fountain Valley, California, United States
4
Site 913
Greenbrae, California, United States