Overview

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

Status:
Completed
Trial end date:
2004-07-01
Target enrollment:
0
Participant gender:
All
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 (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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Solvay Pharmaceuticals
Treatments:
Dronabinol
Ondansetron
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 [AdriamycinÃ’ (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