Hydrazine sulfate_Colorectal Study

Randomized placebo-controlled evaluation of hydrazine sulfate in patients with advanced colorectal cancer

CL Loprinzi, SA Kuross, JR O’Fallon, DH Gesme Jr, JB Gerstner, RM Rospond, CD Cobau and RM Goldberg

Mayo Clinic, Rochester, MN 55905.

PURPOSE: 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.

PATIENTS AND 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.

CONCLUSION: This trial failed to demonstrate any benefit for hydrazine sulfate.

Journal of Clinical Oncology, Vol 12, 1121-1125, 1994

Ann’s NOTE: Hydrazine sulfate is classified as an MAO inhibitor. This means a patient would become very ill if they used some pain killers, tranquilizers and foods. I asked Dr. Loprinzi, lead author of this paper about that at an ASCO 2001 meeting. He responded publicly by stating: “We were not told about that”.

I therefore question the accuracy of these findings. Many patients became extremely ill as a result.