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

This study has been completed.
Sponsor:
Information provided by:
Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier:
NCT00496301
First received: July 3, 2007
Last updated: January 13, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Carcinoma, Renal Cell
Drug: Gemcitabine, Capecitabine and Sorafenib (6 cycles)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Spanish Oncology Genito-Urinary Group:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: every 3 cycles and every two months in patients with "sorafenib" administered as monotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • security profile [ Time Frame: every 3 cycles and every two months in patients with "sorafenib" administered as monotherapy ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: every three cycles and every two months in patients with "Sorafenib" treated as single agent ] [ Designated as safety issue: No ]
  • Global survival [ Time Frame: At last contact date or death date ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: every three cycles and every two months in patients with "Sorafenib" treated as single agent ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2006
Study Completion Date: December 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496301

Locations
Spain
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
Investigators
Study Chair: Joaquim Bellmunt Molins, MD SOGUG
  More Information

No publications provided by Spanish Oncology Genito-Urinary Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Bellmunt Molins, Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov Identifier: NCT00496301     History of Changes
Other Study ID Numbers: SOGUG-02-06
Study First Received: July 3, 2007
Last Updated: January 13, 2009
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms
Capecitabine
Gemcitabine
Sorafenib
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014