SWOG clinical trial number
30987

Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients with Metastatic or Locally Advanced Urothelial Cancer Without Prior Systemic Therapy

Closed
Phase
Published
Abbreviated Title
Advanced Bladder
Activated
06/15/2002
Closed
06/01/2004
Participants
NCORP, Members, UCOP, Medical Oncologists, Surgeons, Pathologists, RTOG, CTSU

Research committees

Genitourinary Cancer

Treatment

Cisplatin Paclitaxel Gemcitabine hydrochloride

Eligibility Criteria Expand/Collapse

Pts must have histologically proven Stage IV locally advanced disease (T4b any N or any T N2-3) or metastatic (M1) transitional cell carcinoma of the urothelium (pure or mixed). Pts should not be suitable for surgery or RT w/curative intent. Pts must have either mx or non-mx (evaluable) disease as defined by RECIST. No prior systemic chemo or inv agents. Loc intravesical chemo or immuno allowed if completed at least 4 wks prior to reg. One course of prior RT allowed if completed at least 4 wks prior to reg. PS WHO 0 or 1. Bili < 1.25 x IULN. SGOT or SGPT < 2.5 x IULN. > 18 yrs and considered fit for cisplatin containing regimens. WBC >/= 3000, PLTS >/= 100,000 and HG >/= 10 g/dl. Estimated life expectancy of at least 12 wks. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance. Adequate renal function - GFR >/= 60 ml/min. Serum Ca w/in normal inst limit. Agree to use appropriate contraception. Pts must not have Grade 3-4 infection w/out neutropenia; known CNS mets; be pregnant or nursing; serious concomitant systemic disorders; prior or concomitant malignancies; Gr 2 or greater peripheral neuropathy or presence of any clinically significant cardiac arrhythmia, CHF or complete bundle brance block functional Class III or worse.

Publication Information Expand/Collapse

2012

Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine (PCG) and gemcitabine/cisplatin (GC) in patients with locally advanced or metastatic urothelial cancer without prior systemic therapy: EORTC intergroup study 30987

J Bellmunt;H von der Maase;GM Mead;N Skonecza;M DeSantis;G Daugaard;J Heyer;N Houede;L Paz-Ares;L Laufman;E Winquist;D Raghavan;S Marreaud;S Collette;R Sylvester;R de Wit Journal of Clinical Oncology 30(10):1107-1113;

PMid: PMID22370319 | PMC number: PMC3341152

2007

Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine (PCG) and gemcitabine/cisplatin (GC) in patients with locally advanced (LA) or metastatic (M) urothelial cancer without prior systemic therapy: EORTC30987/ intergroup study

J Bellmunt;H von der Maase;GM Mead;J Heyer;N Houede;LG Paz-Ares;E Winquist;LR Laufman;R de Wit;R Sylvester Journal of Clinical Oncology 25:18S (June 20 Supplement): LBA5030 (ASCO 2007 meeting - oral presentation)

Other Clinical Trials

SWOG Clinical Trial Number
S2210

S2210, "Targeted Neoadjuvant Treatment for Patients with Localized Prostate Cancer and Germline DNA Repair Deficiency"

Research Committee(s)
Genitourinary Cancer
Activated
08/14/2023
Accrual
2%
Open
Phase
SWOG Clinical Trial Number
S2200
SWOG Clinical Trial Number
CTSU/A031901