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

Condition(s) targeted: Chemotherapy Induced Nausea and Vomiting

Intervention: dronabinol (Drug); ondansetron (Drug); dronabinol/ondansetron (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Solvay Pharmaceuticals

Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals

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.

Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Efficacy Study of Oral Dronabinol Alone and in Combination With Ondansetron Versus Ondansetron Alone in Subjects With Delayed Chemotherapy-Induced Nausea and Vomiting

Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Total response of nausea and vomiting/retching was defined as no vomiting and/or retching, an intensity of nausea of < 5 mm on the visual analog scale (VAS) and no use of rescue medication.

Secondary outcome:

Complete responder rate (no vomiting/retching, intensity of nausea of ≤ 30 mm on the VAS and no use of rescue medication)

Presence or absence of nausea

Episodes of vomiting and/or retching

Duration of nausea and vomiting and/or retching

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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:

1. a moderate-to-high emetogenic regimen, or

2. oxaliplatin at doses employed for treatment of colon cancer, or

3. 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 Criteria:

- 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

Site 970, Tucson, Arizona, United States

Site 908, Pomona, California, United States

Site 909, Los Angeles, California, United States

Site 913, Greenbrae, California, United States

Site 925, Fountain Valley, California, United States

Site 943, Rancho Mirage, California, United States

Site 950, Anaheim, California, United States

Site 921, New Port Richey, Florida, United States

Site 924, Hollywood, Florida, United States

Site 929, New Port Richey, Florida, United States

Site 932, Boynton Beach, Florida, United States

Site 933, Ormond Beach, Florida, United States

Site 940, Lakeland, Florida, United States

Site 922, Marietta, Georgia, United States

Site 914, Orland Park, Illinois, United States

Site 926, Skokie, Illinois, United States

Site 928, Harvey, 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

Site 920, Voorhees, New Jersey, United States

Site 910, Bronx, New York, United States

Site 948, Brooklyn, New York, United States

Site 949, Valhalla, New York, United States

Site 953, Brooklyn, New York, United States

Site 947, Wilmington, North Carolina, United States

Site 902, Bismarck, North Dakota, United States

Site 942, Fargo, North Dakota, United States

Site 944, Columbus, Ohio, United States

Site 934, Oklahoma City, Oklahoma, United States

Site 906, Pittsburgh, Pennsylvania, United States

Site 931, Philadelphia, Pennsylvania, United States

Site 918, Charleston, South Carolina, United States

Site 923, N. Charleston, South Carolina, United States

Site 917, Chattanooga, Tennessee, United States

Site 939, Chattanooga, Tennessee, United States

Site 915, Texarkana, Texas, United States

Site 951, Arlington, Virginia, United States

Starting date: July 2003
Ending date: July 2004
Last updated: March 31, 2008