Clinical trial NCT00496301: Clinical Trial on the Mixture of G, C and S in Treatment of Patients With RCC
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: renal
sorafenib
Unresectable and/or metastatic renal cell cancer
Lead sponsor: Spanish Oncology Genito-Urinary Group
Sponsor class: OTHER
First posted: 2007-07-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression-free survival
timeFrame: every 3 cycles and every two months in patients with "sorafenib" administered as monotherapy
Secondary outcomes:
measure: security profile
timeFrame: every 3 cycles and every two months in patients with "sorafenib" administered as monotherapy
measure: Objective response index (CR/PR) and tumor growth control (CR/PR/SD)
timeFrame: every three cycles and every two months in patients with "Sorafenib" treated as single agent
measure: Duration of response
timeFrame: every three cycles and every two months in patients with "Sorafenib" treated as single agent
measure: Global survival
timeFrame: At last contact date or death date
measure: Time to progression
timeFrame: every three cycles and every two months in patients with "Sorafenib" treated as single agent
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Vall d´Hebron
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Coruña
country: Spain
facility: Hospital Santiago de Compostela
city: Gerona
country: Spain
facility: Hospital Josep Trueta
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
city: Málaga
country: Spain
facility: Hospital Clínico Virgen de la Victoria
city: Pamplona
country: Spain
facility: Clínica Universitaria de Navarra
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Vigo
country: Spain
facility: Hospital Xeral Cies
Study officials:
affiliation: SOGUG
name: Joaquim Bellmunt Molins, MD
role: STUDY_CHAIR
References:
citation: Bellmunt J, Trigo JM, Calvo E, Carles J, Perez-Gracia JL, Rubio J, Virizuela JA, Lopez R, Lazaro M, Albanell J. Activity of a multitargeted chemo-switch regimen (sorafenib, gemcitabine, and metronomic capecitabine) in metastatic renal-cell carcinoma: a phase 2 study (SOGUG-02-06). Lancet Oncol. 2010 Apr;11(4):350-7. doi: 10.1016/S1470-2045(09)70383-3. Epub 2010 Feb 15.