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

Solvay

Status and phase

Completed

Phase 3

Conditions

Chemotherapy Induced Nausea and Vomiting

Treatments

Drug: ondansetron

Drug: placebo

Drug: dronabinol/ondansetron

Drug: dronabinol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00642512

S175.3.102

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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