Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia
- Determine whether omega-3 fatty acids will reverse weight loss in advanced cancer
patients with cachexia.
- Determine the maximum tolerated dose (MTD) of omega-3 fatty acids in these patients
(phase I completed 12/1999).
- Determine whether omega-3 fatty acids will result in an antitumor response.
OUTLINE: This is a randomized, stratified, dose escalation study. Patients are stratified by
the extent of weight loss (2-5 percent or greater than 5 percent in the past month).
Patients receive omega-3 fatty acids orally in two equal doses with/after breakfast and
lunch for 4 months or until weight loss is observed.
Dose is escalated in cohorts of two patients, although dose escalation is allowed in
individual patients. The maximum tolerated dose (MTD) is defined as the highest dose level
at which no greater than one-third of the patients treated, including escalated patients
from a lower dose, experience grade 3 or worse toxicity (phase I completed 12/1999).
Patients are evaluated for cachexia response every 2 weeks, and tumor response every 4 weeks
for a maximum of 4 months. If no response of cachexia or tumor after a 2 month period,
patients will be discontinued from study. Patients will be followed for survival
PROJECTED ACCRUAL: A total of 57-63 patients will be enrolled in the Phase I and II study.
Allocation: Randomized, Primary Purpose: Supportive Care
C. Patrick Burns, MD
Holden Comprehensive Cancer Center
United States: Federal Government
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|New York Presbyterian Hospital - Cornell Campus||New York, New York 10021|
|Holden Comprehensive Cancer Center at The University of Iowa||Iowa City, Iowa 52242-1009|
|North Shore University Hospital||Manhasset, New York 11030|