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

January 13, 2009 updated by: Spanish Oncology Genito-Urinary Group

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)

Main Objective:

To evaluate progression-free survival in patients with unresectable renal cell carcinoma (RCC) treated with a combination of gemcitabine, capecitabine, and sorafenib.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Vall d´Hebron
      • Bilbao, Spain, 48013
        • Hospital de Basurto
      • Coruña, Spain, 15706
        • Hospital Santiago de Compostela
      • Gerona, Spain, 17007
        • Hospital Josep Trueta
      • Huelva, Spain, 21005
        • Hospital Juan Ramón Jimenez
      • Málaga, Spain, 29010
        • Hospital Clínico Virgen de la Victoria
      • Pamplona, Spain, 31008
        • Clinica Universitaria de Navarra
      • Sevilla, Spain, 41009
        • Hospital Virgen Macarena
      • Vigo, Spain, 36204
        • Hospital Xeral Cíes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: every 3 cycles and every two months in patients with "sorafenib" administered as monotherapy
every 3 cycles and every two months in patients with "sorafenib" administered as monotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
security profile
Time Frame: every 3 cycles and every two months in patients with "sorafenib" administered as monotherapy
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)
Time Frame: every three cycles and every two months in patients with "Sorafenib" treated as single agent
every three cycles and every two months in patients with "Sorafenib" treated as single agent
Duration of response
Time Frame: every three cycles and every two months in patients with "Sorafenib" treated as single agent
every three cycles and every two months in patients with "Sorafenib" treated as single agent
Global survival
Time Frame: At last contact date or death date
At last contact date or death date
Time to progression
Time Frame: every three cycles and every two months in patients with "Sorafenib" treated as single agent
every three cycles and every two months in patients with "Sorafenib" treated as single agent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Oncology Genito-Urinary Group

Investigators

  • Study Chair: Joaquim Bellmunt Molins, MD, SOGUG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

July 3, 2007

First Submitted That Met QC Criteria

July 3, 2007

First Posted (Estimate)

July 4, 2007

Study Record Updates

Last Update Posted (Estimate)

January 14, 2009

Last Update Submitted That Met QC Criteria

January 13, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOGUG-02-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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