Treatment for renal cancer

A phase II, multicenter, non randomized, clinical study of Gemcitabine, ,Capecitabine and Sorafenib (BAY 43-9006) combination for the treatment of non resectable and/or metastatic patients with renal cell carcinome.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-003429-95-ES

Enrollment

Registered

2012-03-29

Start date

2006-10-19

Completion date

Unknown

Last updated

2012-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NON RESECTABLE AND / OR METASTATIC RENAL CELL CARCINOMA MedDRA version: 14.1 Level: LLT Classification code 10038484 Term: Renal neoplasia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: SORAFENIB Product Code: BAY 43-9006 Pharmaceutical Form: Coated tablet INN or Proposed INN: sorafenib Current Sponsor code: bay 43-9006 Concentration unit: mg milligram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who are able to give written informed consent.Patient informed constent must be obtained before any study specific procedure. 2.- Patients with non resectable and/or metastatic clear renal cell carcinoma histologically or citologically confirmed. papilares, cromófobos o histologias mixtas 3.- Patients who are not candidate to immunotherapy, according to predictive response factors or are intolerant to immunotherapy treatment. 4.- Patients with favorable or intermediate Motzer risk classification 5.- Age 18 years or older 6.- ECOG 0 to 1 7.- Measurable or evaluable disease 8.- Adequate hematopoietic (absolute neutrophil count > or = 1.5 x 10(9)/L; platelet count > or = 100 x 10(9) and hemoglobin > or = 10 g/dl) 9.- Adequate hepatic and renal functions defined as: bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1.- Papilar carcinoma, Bellini carcinoma, medular carcinoma and other less frequent renal cell carcinoma histologies. Pacientes con subtipos poco comunes de CCR como tumor de células papilares puro, carcinoma de Bellini, carcinoma medular o tumores oncocíticos cromófobos y variantes sarcomatoides quedarán excluidos del estudio. 3.- Patients that due to their clinical characteristic it is expected to have a potential benefit with immunotherapy treatment. 4.- Patients with high risk Motzer classification2.- Concomitant treatment with other chemotherapy or immunotherapy 5.- No previous malignancy except cervical carcinoma in situ, adequately treated basal cell carcinoma,superficial bladder tumors, or other malignancies curatively treated > 5 years before study entry. 6.- Previous history of congestive heart failure, active coronary disease or cardiac ischemia (Acute myocardial infartion within 6 previous months) or serious cardiac arrhythmias which require treatment. 7.- No history of HIV infection, cronic hepatitis B or C or any active clinically serious infections requiring systemic therapy. 8.- No pregnacy or lactanting females7.- Patients with seizures who require anticonvulsivant treatment. 9.- Clinically suspected or history of leptomeningeal involvement. 10.- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg ordiastolic pressure > 90 mmHg, despite optimal medical management.

Design outcomes

Primary

Measure	Time frame
Main Objective: Progression free survival defined as the time relapsed between first treatment administration and progressive disease (clinical o radiological) or death (any cause).;Secondary Objective: To evaluate toxicity profile To evaluate response rate (CR and PR) and tumor growth control (CR + PR + SD) Duration of response Overall survival Time to progression defined as the time elapse between first treatment administration and progressive disease.;Primary end point(s): Progression free survival defined as the time elapsed between first treatment administration and progressive disease (clinical or radiological) or death (any cause).;Timepoint(s) of evaluation of this end point: End of the study	—

Measure

Time frame

Main Objective: Progression free survival defined as the time relapsed between first treatment administration and progressive disease (clinical o radiological) or death (any cause).;Secondary Objective: To evaluate toxicity profile To evaluate response rate (CR and PR) and tumor growth control (CR + PR + SD) Duration of response Overall survival Time to progression defined as the time elapse between first treatment administration and progressive disease.;Primary end point(s): Progression free survival defined as the time elapsed between first treatment administration and progressive disease (clinical or radiological) or death (any cause).;Timepoint(s) of evaluation of this end point: End of the study

—

Secondary

Measure	Time frame
Secondary end point(s): Safety profile, Objective response index (CR/PR) and control of tumor growth (CR/PR/SD), Duration of the response, Overall survival, Time to progression;Timepoint(s) of evaluation of this end point: End of the study	—

Countries

Spain

Contacts

Public ContactSOGUG

SOGUG, Grupo español para el estudio del cancer genitourinario

3493 248 36 11

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026