Carcinoma, Renal Cell
Conditions
Keywords
renal, sorafenib, Unresectable and/or metastatic renal cell cancer
Brief 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.
Interventions
DRUGGemcitabine, Capecitabine and Sorafenib (6 cycles)
Gemcitabine: 1000 mg/m2 i.v. days 1 and 8. Capecitabine: 650 mg/m2 i.v. day 1 to 14. (change to 500mg/m2 after amendment nº2 (dated on 10/10/2007) Sorafenib:400 mg/12h v.o. day 1 to 21
Sponsors
Spanish Oncology Genito-Urinary Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | every 3 cycles and every two months in patients with sorafenib administered as monotherapy |
Secondary
| Measure | Time frame |
|---|---|
| Global survival | At last contact date or death date |
| security profile | every 3 cycles and every two months in patients with sorafenib administered as monotherapy |
| Objective response index (CR/PR) and tumor growth control (CR/PR/SD) | every three cycles and every two months in patients with Sorafenib treated as single agent |
| Duration of response | every three cycles and every two months in patients with Sorafenib treated as single agent |
| Time to progression | every three cycles and every two months in patients with Sorafenib treated as single agent |
Countries
Spain
Outcome results
None listed