Cisplatin Plus Gemcitabine With or Without Paclitaxel in Treating Patients With Stage IV Urinary Tract Cancer

Phase 3 Completed 608 enrolled European Organisation for Research and Treatment of Cancer - EORTC Central European Cooperative Oncology Group · collab German Association of Urologic Oncology · collab Groupe D'Etude des Tumeurs Uro-Genitales · collab Institute of Cancer Research, United Kingdom · collab Medical Research Council · collab NCIC Clinical Trials Group · collab National Cancer Institute (NCI) · collab SWOG Cancer Research Network · collab Spanish Oncology Genito-Urinary Group · collab

RandomizedOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for urinary tract cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin plus gemcitabine with or without paclitaxel in treating patients who have stage IV urinary tract cancer.

Timeline

Start: 2001-05
Primary completion: 2004-06
Completion: —

Outcome

Missed primary endpoint

paper the median OS was 15.8 months on PCG versus 12.7 months on GC (hazard ratio [HR], 0.85; P = .075). PMID 22370319 ↗

Publications

Results Bellmunt J, von der Maase H, Mead GM, Skoneczna I, De Santis M, Daugaard G, Boehle A, Chevreau C, Paz-Ares L, Laufman LR, Winquist E, Raghavan D, Marreaud S, Collette S, Sylvester R, de Wit R. Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine and gemcitabine/cisplatin in patients with locally advanced or metastatic urothelial cancer without prior systemic therapy: EORTC Intergroup Study 30987. J Clin Oncol. 2012 Apr 1;30(10):1107-13. doi: 10.1200/JCO.2011.38.6979. Epub 2012 Feb 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	—	Intravenous
Subject	Gemcitabine	Small molecule	—	Intravenous
Subject	Paclitaxel	Small molecule	—	Intravenous