Dronabinol Versus Standard Ondansetron Antiemetic Therapy in Preventing Delayed-Onset Chemotherapy-Induced Nausea and Vomiting

Completed · Phase 3 · Has a placebo group

Conditions studied: Chemotherapy Induced Nausea and Vomiting

In brief

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 (CINV) or retching by measuring the incidence of total response of nausea and vomiting and/or retching following administration of moderate-to-high emetogenic chemotherapeutic agents.

Key facts

Study ID

NCT00642512

Run by

Solvay Pharmaceuticals

People needed

64

Starts

2003-07-01

Expected to finish

2004-07-01

Last updated by the study team

2008-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Site 970 — Tucson, Arizona, United States
• Site 950 — Anaheim, California, United States
• Site 925 — Fountain Valley, California, United States
• Site 913 — Greenbrae, California, United States
• Site 909 — Los Angeles, California, United States
• Site 908 — Pomona, California, United States
• Site 943 — Rancho Mirage, California, United States
• Site 932 — Boynton Beach, Florida, United States
• Site 924 — Hollywood, Florida, United States
• Site 940 — Lakeland, Florida, United States
• Site 921 — New Port Richey, Florida, United States
• Site 929 — New Port Richey, Florida, United States
• Site 933 — Ormond Beach, Florida, United States
• Site 922 — Marietta, Georgia, United States
• Site 928 — Harvey, Illinois, United States
• Site 914 — Orland Park, Illinois, United States
• Site 926 — Skokie, Illinois, United States
• Site 946 — Springfield, Illinois, United States
• Site 956 — Terre Haute, Indiana, United States
• Site 905 — Southfield, Michigan, United States
• Site 916 — Fergus Falls, Minnesota, United States
• Site 937 — Greenwood, Mississippi, United States
• Site 958 — St Louis, Missouri, United States
• Site 904 — Missoula, Montana, United States
• Site 919 — Little Silver, New Jersey, United States

Full record on ClinicalTrials.gov

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