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
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
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
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
S2200, A Phase II Randomized Trial of Cabozantinib with or Without Atezolizumab in Patients with Advanced Papillary Renal Cell Carcinoma: PAPMET2
Research Committee(s)
Genitourinary Cancer
Activated
09/19/2022
Accrual
6%
Open
Phase
SWOG Clinical Trial Number
CTSU/A031901
Duration of Immune Checkpoint Therapy in Locally Advanced or Metastatic Urothelial Carcinoma: A Randomized Phase 3 Non-Inferiority Trial
Research Committee(s)
Genitourinary Cancer
Activated
05/01/2021
Open
Phase