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

NCT00496301 | Completed Phase 2 DMC

• 1 other identifier: SOGUG-02-06
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 10

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.

Conditions

Carcinoma, Renal Cell

Keywords

renal; sorafenib; Unresectable and/or metastatic renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

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

Secondary Outcomes (5)

• security profile

  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)

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

• Duration of response

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

• Global survival

  At last contact date or death date

• Time to progression

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

Interventions

Gemcitabine, Capecitabine and Sorafenib (6 cycles) DRUG

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

Also known as: Gemzar, Xeloda, Nexavar

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Spanish Oncology Genito-Urinary Group: lead

Study Sites (10)

Hospital Santiago de Compostela

A Coruña, 15706, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Vall d´Hebron

Barcelona, 08035, Spain

Location

Hospital de Basurto

Bilbao, 48013, Spain

Location

Hospital Josep Trueta

Girona, 17007, Spain

Location

Hospital Juan Ramón Jiménez

Huelva, 21005, Spain

Location

Hospital Clínico Virgen de la Victoria

Málaga, 29010, Spain

Location

Clínica Universitaria de Navarra

Pamplona, 31008, Spain

Location

Hospital Virgen Macarena

Seville, 41009, Spain

Location

Hospital Xeral Cies

Vigo, 36204, Spain

Location

Related Publications (1)

• 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.

  PMID: 20163987 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Gemcitabine; Capecitabine; Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Pyridines

Study Officials

• Joaquim Bellmunt Molins, MD

  SOGUG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: November 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 14, 2009

Record last verified: 2009-01

Locations

ES (10)