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Carcinoma, Renal CellPhase 2SOGUG-02-06NCT00496301

Clinical Trial on the Mixture of G, C and S in Treatment of Patients With RCC

A Phase 2 study testing Gemcitabine, Capecitabine and Sorafenib (6 cycles) in people with Carcinoma, Renal Cell, run by Spanish Oncology Genito-Urinary Group at 10 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Gemcitabine, Capecitabine and Sorafenib (6 cycles)
Type of treatment
Injection or infusion
How many people
40 participants
Where
10 sitesSpain
Study dates
Nov 2006to Dec 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Spain10 sites

  • Hospital Santiago de Compostela

    A Coruña, 15706

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Vall d´Hebron

    Barcelona, 08035

  • Hospital de Basurto

    Bilbao, 48013

  • Hospital Josep Trueta

    Girona, 17007

  • Hospital Juan Ramón Jiménez

    Huelva, 21005

  • Hospital Clínico Virgen de la Victoria

    Málaga, 29010

  • Clínica Universitaria de Navarra

    Pamplona, 31008

  • Hospital Virgen Macarena

    Seville, 41009

  • Hospital Xeral Cies

    Vigo, 36204

Other trials in Spain

About this study

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)

Main Objective:

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

Being tested
Gemcitabine, Capecitabine and Sorafenib (6 cycles)
Keywords
renal, sorafenib, Unresectable and/or metastatic renal cell cancer
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gemcitabine, Capecitabine and Sorafenib (6 cycles)Drug

    Also called Gemzar, Xeloda, Nexavar

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival

    Measured: every 3 cycles and every two months in patients with "sorafenib" administered as monotherapy

Secondary outcomes (5)

  1. security profile

    Measured: 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)

    Measured: every three cycles and every two months in patients with "Sorafenib" treated as single agent

  3. Duration of response

    Measured: every three cycles and every two months in patients with "Sorafenib" treated as single agent

  4. Global survival

    Measured: At last contact date or death date

  5. Time to progression

    Measured: every three cycles and every two months in patients with "Sorafenib" treated as single agent

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2007 (estimated)
  2. Study startNov 2006
  3. Primary completionApr 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00496301
Sponsor's protocol ID
SOGUG-02-06
Acronym
SOGUG-02-06
Status last verified
Jan 2009
First submitted
3 Jul 2007
Last updated
14 Jan 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20163987

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Capecitabine and Sorafenib (6 cycles) in people with Carcinoma, Renal Cell, run by Spanish Oncology Genito-Urinary Group at 10 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: every 3 cycles and every two months in patients with "sorafenib" administered as monotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00496301, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2009.

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