Clinical trial NCT00496301 (phase 2, status: completed)
Conditions: carcinoma, renal cell
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: gemcitabine, capecitabine and sorafenib (6 cycles)
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must give their written informed consent before any procedure related to the
             study is performed; therefore, it must be given at the selection visit. The patient
             must be informed that he has the right to withdraw from the study at any time, without
             any kind of prejudice.

          -  Patients with renal clear cell carcinoma (RCC), unresectable and/or metastatic,
             histologically or cytologically documented (excluding the less common subtypes).

          -  Patients must not be candidates for any immunotherapeutic treatment, according to the
             response predictive factors, or must be intolerant to immunotherapeutic treatment.

          -  Patients classified as having median or low risk, according to Motzer's scoring.

          -  Patients (men or women) with ages equal or superior to 18 years old.

          -  ECOG ≤ 1.

          -  Assessable or measurable disease.

          -  Patients with adequate haematological function, defined as:

               -  Neutrophils ≥ 1.5 x 10^9/L

               -  Blood platelets ≥ 100 x 10^9/L

               -  Haemoglobin ≥ 10 g/dl

          -  Patients with adequate hepatic, renal, medullar and coagulation function, according to
             the following criteria:

               -  Total bilirubin < 1.5 times the superior limit of normality

               -  ALT and AST < 2.5 times the superior limit of normality (< 5 times the superior
                  limit of normality in case of liver failure due to cancer)

               -  Amylase and lipase < 1.5 times the superior limit of normality

               -  Serum creatinine < 2 times the superior limit of normality

               -  TP or INR and TTP < 1.5 times the superior limit of normality. If patient is
                  receiving anticoagulants, strict monitoring will be carried out, with evaluations
                  on a weekly basis, at least, until the INR is stable, referring to a
                  determination previous to dose administration, according to local standard care.

          -  Patients with a life expectancy superior to 12 weeks, at least.

          -  Patients may have received radiotherapy; however, this must not be the only target
             lesion.

          -  Patients from both sexes must use adequate contraceptive methods (oral or injectable
             contraceptives, intrauterine device, condom, sterilization) whilst participating in
             the protocol. After the retreat of treatment with BAY 43-9006, the contraceptive
             methods must be used for 4 weeks in women and for 3 months in men.

          -  Patients who are capable of accomplishing the study's requirements and without any
             impediments to follow the instructions while on study

        Exclusion Criteria:

          -  Patients who do not give their written informed consent to participate in the study.

          -  Patients with less common RCC subtypes, such as pure papillary cell tumours, Bellini
             carcinoma, medullary carcinoma or the oncocytic chromophobes and sarcomatoid variants,
             will be excluded from the study.

          -  Patients that have received previous treatment with chemotherapy or that had tumours
             that evolved during or after immunotherapy treatment.

          -  Patients that, due to their characteristics, may obtain a potential benefit from
             immunotherapy treatment.

          -  Patients that have received previous anti-angiogenic treatment.

          -  High-risk patients according to Motzer's classification.

          -  Concomitant treatment with another chemotherapy or immunotherapy.

          -  Arterial uncontrolled hypertension, which is defined as a systolic arterial pressure
             value > 150 mmHg or diastolic arterial pressure value > 90 mmHg, despite adequate
             medical treatment.

          -  Patients with a primary cancer diagnosis different from RCC, except in situ cervical
             carcinoma, baseline cellular carcinomas or superficial bladder tumours, prostate
             cancer pT1 gleason < 6 or other malign tumours which have received curative treatment
             > 5 years previous to the inclusion in this study.

          -  Cardiac arrhythmia antecedents, that require treatment with anti-arrhythmics (except
             for beta-blockers or digoxin), symptomatic coronary disease or ischemia (myocardial
             infarction in the previous 6 months) or congestive cardiac insufficiency > New York
             Heart Association (NYHA) class II

          -  Patients with active bacterial or fungal infectious processes, which are considered
             severe from the clinical point of view (≥ Common Terminology Criteria from the
             National Cancer Institute [CTC from NCI] grade 2, version 3)

          -  Patients that present previously known positive serology for HIV or chronic hepatitis
             B or C.

          -  Antecedents of organ allograft.

          -  Meningeal carcinomatosis or symptomatic uncontrolled cerebral disease.

          -  Patients with epileptic disorders that require medication (such as antiepileptics).

          -  All unstable conditions that could put the patient's security and/or his study
             accomplishment in danger.

          -  Abuse of substances, clinical conditions, psychological or social, that may interfere
             with the patient's participation in the study or with the evaluation of the study's
             results.

          -  Patients that present any contraindication or allergy to the study's investigational
             product.

          -  Patients that are participating or that have participated in any clinical trial in the
             4 weeks previous to inclusion.

          -  Pregnant or breastfeeding women. Women of fertile age must have a negative result in
             the pregnancy test performed 7 days before the beginning of the administration of the
             study medication. Both men and women included in the study must use an adequate
             contraceptive method.