clinical trial on the mixture of g, c and s in treatment of patients with rcc

Conditions: Carcinoma, Renal Cell

Summary: main objective: to evaluate progression-free survival in patients with unresectable renal cell carcinoma (rcc) treated with a combination of gemcitabine, capecitabine, and sorafenib.


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 \ 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.

Keywords: renal sorafenib unresectable and/or metastatic renal cell cancer