Randomized placebo-controlled evaluation of hydrazine sulfate in patients with advanced colorectal cancer.
OBJECTIVE
Hydrazine sulfate is a controversial agent that was originally studied in cancer patients approximately 20 years ago. Based on a series of recent trials that suggested that this drug might have utility in cancer patients, we conducted this study.


METHODS
Patients with metastatic colorectal cancer were randomized to receive hydrazine sulfate or placebo in a double-blinded manner. Protocol patients did not concurrently receive any other systemic antineoplastic treatment.


RESULTS
There were 127 assessable patients entered onto this clinical trial. Data from the study showed trends both for poorer survival and for poorer quality of life (QL) in the hydrazine group. There were no significant differences in the two study arms with regard to anorexia or weight loss.


CONCLUSIONS
This trial failed to demonstrate any benefit for hydrazine sulfate.
Loprinzi
C L
CL
Mayo Clinic, Rochester, MN 55905.
Kuross
S A
SA
O'Fallon
J R
JR
Gesme
D H
DH
Gerstner
J B
JB
Rospond
R M
RM
Cobau
C D
CD
Goldberg
R M
RM
D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006834:Hydrazines / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D015996:Survival Rate
D000970:Antineoplastic Agents; D006834:Hydrazines; C029424:hydrazine