Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Phase 3 Completed 300 enrolled National Medical Research Council (NMRC), Singapore

RandomizedDouble-blindTreatment

Summary

RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using megestrol may fight liver cancer by blocking the uptake of estrogen. It is not yet known if megestrol is an effective treatment for liver cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in treating patients who have liver cancer that cannot be removed by surgery.

Timeline

Start: 2002-05
Primary completion: 2007-06
Completion: 2011-08

Outcome

Missed primary endpoint

paper An adverse but not statistically significant difference in OS was found for MA vs placebo PMID 21863030 ↗

paper median values 1.88 and 2.14 months, respectively (hazard ratio (HR)=1.25, 95% CI=0.92-1.71, P=0.16). PMID 21863030 ↗

Publications

Results Chow PK, Machin D, Chen Y, Zhang X, Win KM, Hoang HH, Nguyen BD, Jin MY, Lobo R, Findlay M, Lim CH, Tan SB, Gandhi M, Soo KC; Asia-Pacific Hepatocellular Carcinoma Trials Group. Randomised double-blind trial of megestrol acetate vs placebo in treatment-naive advanced hepatocellular carcinoma. Br J Cancer. 2011 Sep 27;105(7):945-52. doi: 10.1038/bjc.2011.333. Epub 2011 Aug 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Megestrol Acetate	Other / unclassified	320 mg	Oral