Placebo-controlled trial of hydrazine sulfate in patients with newly diagnosed non-small-cell lung cancer

J Clin Oncol. 1994 Jun;12(6):1126-9. doi: 10.1200/JCO.1994.12.6.1126.


Purpose: 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.

Patients and 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).

Conclusion: This trial failed to demonstrate any benefit for patients who received hydrazine sulfate.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Carcinoma, Non-Small-Cell Lung / diagnosis
  • Carcinoma, Non-Small-Cell Lung / drug therapy*
  • Carcinoma, Non-Small-Cell Lung / mortality
  • Cisplatin / administration & dosage
  • Double-Blind Method
  • Etoposide / administration & dosage
  • Female
  • Humans
  • Hydrazines / adverse effects
  • Hydrazines / therapeutic use*
  • Lung Neoplasms / diagnosis
  • Lung Neoplasms / drug therapy*
  • Lung Neoplasms / mortality
  • Male
  • Quality of Life
  • Survival Rate


  • Antineoplastic Agents
  • Hydrazines
  • hydrazine
  • Etoposide
  • Cisplatin