Irinotecan and Cisplatin in Treating Patients With Locally Advanced or Metastatic Penile Cancer

Phase 2 Completed European Organisation for Research and Treatment of Cancer - EORTC

Open-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy such as irinotecan and cisplatin use different ways to stop tumor cells from dividing so they stop growing or die. Combining irinotecan with cisplatin may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining irinotecan with cisplatin in treating patients who have locally advanced or metastatic penile cancer.

Timeline

Start: 2003-06
Primary completion: 2006-01
Completion: —

Outcome

Missed primary endpoint

paper The study fails to demonstrate a response rate significantly >30%. PMID 18417462 ↗

Publications

Results Theodore C, Skoneczna I, Bodrogi I, Leahy M, Kerst JM, Collette L, Ven K, Marreaud S, Oliver RDT; EORTC Genito-Urinary Tract Cancer Group. A phase II multicentre study of irinotecan (CPT 11) in combination with cisplatin (CDDP) in metastatic or locally advanced penile carcinoma (EORTC PROTOCOL 30992). Ann Oncol. 2008 Jul;19(7):1304-1307. doi: 10.1093/annonc/mdn149. Epub 2008 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	80 mg/m2	Intravenous
Subject	Irinotecan	Small molecule	60 mg/m2	Intravenous