A PHASE II STUDY OF BAY 43-9006 IN COMBINATION WITH WEEKLY GEMCITABINE FOR THE TREATMENT OF METASTATIC RCC EITHER UNSUITABLE FOR OR REFRACTORY TO PRIOR TREATMENT WITH CYTOKINES - TAGUSG6

Conditions: METASTATIC RENAL CANCER CELL
MedDRA version: 8.1Level: PTClassification code 10050018Term: Renal cancer metastatic

Registration Number: EUCTR2006-000231-95-IT

Lead Sponsor: IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 43

Inclusion Criteria

- Written informed consent - Advanced, histologically confirmed, RCC - ECOG PS 0-2 - Age 18 years - UISS 3 cathegory see appendix or immunotherapy refractory disease indipendently of UISS cathegory . - Presence of measurable disease - Adequate blood counts WBC 3.000/ml; HB 10 gr/dl; Ptl 100.000/ml liver Transaminases 2N; bilirubin 2N and kidney creatinine 2 ng/ml function tests.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Brain metastasis - Comorbid conditions which could represent a contraindication to receive the drugs on study or to jeopardize patient compliance - Unstable diabetes; active coronary disease; active serious infections - Recent gastrointestinal bleeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To evaluate the response expressed as clinical benefit to the combination of Gemcitabine and BAY 43-9006 in women and men with metastatic RCC either unsuitable for or refractory to prior treatment with cytokines.;Secondary Objective: - To evaluate progression-free survival, overall survival, response duration, time to response. - To evaluate the combined regimen with respect to change in QoL status. - To evaluate the possible predictive value of baseline phosho ERK pERK , VEGFr 2 and 3 in tumour cells and of VEGF serum levels in determining tumor response.;Primary end point(s): To evaluate the response expressed as clinical benefit to the combination of Gemcitabine and BAY 43-9006 in women and men with metastatic RCC either unsuitable for or refractory to prior treatment with cytokines.

Secondary Outcome Measures