Clinical Trial on the Mixture of G, C and S in Treatment of Patients With RCC (SOGUG-02-06)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00496301
Recruitment Status : Completed
First Posted : July 4, 2007
Last Update Posted : January 14, 2009
Information provided by:
Spanish Oncology Genito-Urinary Group

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: Gemcitabine, Capecitabine and Sorafenib (6 cycles) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : December 2008

Intervention Details:
  • Drug: Gemcitabine, 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
    Other Names:
    • Gemzar
    • Xeloda
    • Nexavar

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: every 3 cycles and every two months in patients with "sorafenib" administered as monotherapy ]

Secondary Outcome Measures :
  1. security profile [ Time Frame: every 3 cycles and every two months in patients with "sorafenib" administered as monotherapy ]
  2. Objective response index (CR/PR) and tumor growth control (CR/PR/SD) [ Time Frame: every three cycles and every two months in patients with "Sorafenib" treated as single agent ]
  3. Duration of response [ Time Frame: every three cycles and every two months in patients with "Sorafenib" treated as single agent ]
  4. Global survival [ Time Frame: At last contact date or death date ]
  5. Time to progression [ Time Frame: every three cycles and every two months in patients with "Sorafenib" treated as single agent ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00496301

Hospital del Mar
Barcelona, Spain, 08003
Hospital Vall d´Hebron
Barcelona, Spain, 08035
Hospital de Basurto
Bilbao, Spain, 48013
Hospital Santiago de Compostela
Coruña, Spain, 15706
Hospital Josep Trueta
Gerona, Spain, 17007
Hospital Juan Ramón Jiménez
Huelva, Spain, 21005
Hospital Clínico Virgen de la Victoria
Málaga, Spain, 29010
Clínica Universitaria de Navarra
Pamplona, Spain, 31008
Hospital Virgen Macarena
Sevilla, Spain, 41009
Hospital Xeral Cies
Vigo, Spain, 36204
Sponsors and Collaborators
Spanish Oncology Genito-Urinary Group
Study Chair: Joaquim Bellmunt Molins, MD SOGUG

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Bellmunt Molins, Spanish Oncology Genito-Urinary Group Identifier: NCT00496301     History of Changes
Other Study ID Numbers: SOGUG-02-06
First Posted: July 4, 2007    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 2009

Keywords provided by Spanish Oncology Genito-Urinary Group:
Unresectable and/or metastatic renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors
Vitamin B Complex