Phase II Clinical Trial, Non-Randomized, Multicentre, on the Combination of Gemcitabine, Capecitabine and Sorafenib (Bay 43-9006) in Treatment of Patients With Unresectable and/or Metastatic Renal Cell Carcinoma (RCC)
- 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
- 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
- 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
- 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
- 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
- Patients that present any contraindication or allergy to the study's investigational
- 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