From "Alternative Cancer Cures: Unproven or Disproven"? by Dr. Vickers is Assistant Attending Research Methodologist, Memorial Sloan-Kettering Cancer Center, New York, NY. This is the section on Hydrazine Sulfate: Although hydrazine sulfate is a synthetic drug, it is included here because it is taken by cancer patients as an alternative therapy and because it is based on a therapeutic rationale quite unlike any other currently licensed cancer drug. Several early clinical trials seemed to indicate possible benefit from hydrazine sulfate. Chlebowski et al., for example, randomized 65 patients with advanced nonsmall cell cancer to receive hydrazine sulfate plus chemotherapy or chemotherapy alone. Overall survival was nonsignificantly higher in the hydrazine sulfate group (median survival, 292 versus 197 days; P = 0.11). There were statistically significant differences for some secondary endpoints, such as caloric intake, but not others, such as weight gain.15 On the basis of the trend toward increased survival seen in this study, three randomized, placebo-controlled trials were conducted to determine whether hydrazine sulfate could improve survival or quality of life. The studies included, respectively, 243 patients with newly diagnosed nonsmall cell lung cancer concurrently treated with etoposide and cisplatin,16 128 patients with advanced colorectal cancer receiving no other oncologic therapy,17 and 291 patients receiving cisplatin and vinblastine for advanced nonsmall cell lung cancer.18 Hydrazine sulfate did not improve survival in any of these settings. The survival curves were essentially overlapping in the two lung cancer trials; the colorectal cancer trial was stopped early because of excess deaths in the hydrazine arm (P = 0.034). Survival was poor in all three trials, with over 90% of patients dying during a one- to two-year follow-up. References: 15) Chlebowski RT, Bulcavage L, Grosvenor M, et al. Hydrazine sulfate influence on nutritionalstatus and survival in non-small-cell lung cancer. J Clin Oncol 1990; 8: 9–15. 16) Loprinzi CL, Goldberg RM, Su JQ, et al. Placebo-controlled trial of hydrazine sulfate in patients with newly diagnosed non-small-cell lung cancer. J Clin Oncol 1994; 12: 1126–1129. 17)Loprinzi CL, Kuross SA, O’Fallon JR, et al. Randomized placebo-controlled evaluation of hydrazine sulfate in patients with advanced colorectal cancer. J Clin Oncol 1994; 12: 1121–1125. 18) Kosty MP, Fleishman SB, Herndon JE, et al. Cisplatin, vinblastine, and hydrazine sulfate in advanced, non-small-cell lung cancer: a randomized placebo-controlled, double-blind phase III study of the Cancer and Leukemia Group B. J Clin Oncol 1994; 12: 1113–1120. J Clin Oncology, 1990 J Clin Oncology, 1994 J Clin Oncology, 1994 J Clin Oncology, 1994 Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.