Placebo-controlled trial of hydrazine sulfate in patients with newly diagnosed non-small-cell lung cancer.
OBJECTIVE
Hydrazine sulfate, an agent that appears to inhibit gluconeogenesis, has been studied in cancer patients for approximately 20 years. There was a recent resurgence of interest in this drug when subset analysis of a small placebo-controlled, double-blind, clinical trial reported improved survival among non-small-cell lung cancer patients with a good performance status who were randomized to receive this drug along with standard chemotherapy.


METHODS
Patients on this trial had newly diagnosed, unresectable non-small-cell lung cancer and were treated with cisplatin and etoposide. In addition, they were randomized to receive hydrazine sulfate or placebo in a double-blind manner.


RESULTS
A total of 243 patients were randomized. Response rates were similar in the two treatment arms. There were trends for worse time to progression and survival in the hydrazine sulfate arm. No significant differences were noted in the two study arms with regard to toxicity or quality of life (QL).


CONCLUSIONS
This trial failed to demonstrate any benefit for patients who received hydrazine sulfate.
Loprinzi
C L
CL
Mayo Clinic, Rochester, MN 55905.
Goldberg
R M
RM
Su
J Q
JQ
Mailliard
J A
JA
Kuross
S A
SA
Maksymiuk
A W
AW
Kugler
J W
JW
Jett
J R
JR
Ghosh
C
C
Pfeifle
D M
DM
D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D002945:Cisplatin / Q000008:administration & dosage; D004311:Double-Blind Method; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D006834:Hydrazines / Q000009:adverse effects / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D011788:Quality of Life; D015996:Survival Rate
D000970:Antineoplastic Agents; D006834:Hydrazines; C029424:hydrazine; D005047:Etoposide; D002945:Cisplatin