A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients With Stage IIIb With Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)

Last updated: April 3, 2015
Sponsor: Bayer
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT00449033
12006
2006-002688-26
  • Ages > 18
  • All Genders

Study Summary

Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age > 18 years old

  • Stage IIIB (with cytologically confirmed malignant pleural or pericardial effusion) orStage IV histological or cytological confirmation of NSCLC of non-squamous cellcarcinoma subtype. (thoracentesis or pericardiocentesis is not necessary if a biopsyof the original tumor is available to confirm diagnosis of NSCLC).

  • Patients with at least one measurable lesion. Lesions must be measured by CT-scan orMRI (Magnetic resonance imaging) according to Response Evaluation Criteria in SolidTumors (RECIST, see Appendix 10.3)

  • Life expectancy of at least 12 weeks

  • Adequate bone marrow, liver and renal function as assessed by the following laboratoryrequirements to be conducted within 7 days prior to start of first dose:

  • Hemoglobin >/= 9.0 g/dl (>/= 5.6 mmol/l)

  • Absolute neutrophil count (ANC) >/= 1,500/mm3

  • Platelet count >/= 100,000/µl

  • Total bilirubin </= 1.5 x upper limit of normal

  • Alanine transaminase (ALT) and Aspartate transaminase (AST) </= 2.5 x upper limit ofnormal (</= 5 x upper limit of normal for patients with liver involvement of theircancer)

  • Alkaline Phosphatase </= 4 x upper limit of normal

  • PT-INR (Prothrombin Time - International Normalized Ratio) (international normalizedratio of PT) /PTT (Partial Thromboplastin Time) < 1.5 x upper limit of normal

  • Serum Creatinine </= 1.5 times the upper limit of normal and Serum CreatinineClearance >/= 70ml/min

  • Ability to understand and the willingness to sign a written informed consent. A signedinformed consent must be obtained prior to performing any study specific procedures.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion

Exclusion Criteria:

  • Excluded medical conditions:

  • Cardiac disease: Congestive heart failure > class II NYHA (New York HeartAssociation). Patients must not have unstable angina (anginal symptoms at rest)or active coronary artery disease (CAD), or myocardial infarction within the past 6 months

  • Cardiac arrhythmias requiring anti-arrhythmic therapy

  • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg ordiastolic pressure > 90 mmHg, despite optimal medical management.

  • History of HIV (Human immunodeficiency virus) infection or chronic hepatitis B orC

  • Active clinically serious infections (> grade 2 NCI-CTCAE (National CancerInstitute Common Terminology Criteria for Adverse Events) version 3.0)

  • Patients with seizure disorder requiring medication (such as steroids oranti-epileptics)

  • Known brain metastasis. Patients with neurological symptoms should undergo a CTscan/MRI of the brain to exclude brain metastasis.

  • History of organ allograft

  • Patients with evidence or history of bleeding diathesis or coagulopathy

  • Patients undergoing renal dialysis

  • Cancer other than NSCLC within 5 years prior to start of study treatment EXCEPTcervical carcinoma in situ, treated basal cell carcinoma, or superficial bladdertumors [Ta (Noninvasive tumor), Tis (Carcinoma in situ) & T1 (Tumor invadeslamina propria)]

  • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg ordiastolic pressure > 90 mmHg, despite optimal medical management.

  • Thrombotic or embolic events such as cerebrovascular accident including transientischemic attacks within the past 6 months

  • Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for AdverseEvents (CTCAE) Grade 2 within 4 weeks of first dose of study drug

  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first doseof study drug

  • Serious, non-healing wound, ulcer, or bone fracture

  • Uncorrected dehydration

  • Pregnant or breast-feeding patients. Women of childbearing potential must have anegative pregnancy test performed within 7 days of the start of treatment. Bothmen and women enrolled in this trial must use adequate birth control measuresduring the course of the trial. The definition of effective contraception will bebased on the judgment of the principal investigator or a designated associate.

  • Substance abuse, medical, psychological or social conditions that may interferewith the patient's participation in the study or evaluation of the study results

  • Known or suspected allergy to the investigational agent or any agent given inassociation with this trial

  • Any condition that is unstable or could jeopardize the safety of the patient andtheir compliance in the study

  • Patients unable to swallow oral medications

  • Any malabsorption condition

  • Patients with a hearing impairment (FOR GERMANY ONLY)

  • NSCLC patients with squamous cell carcinoma diagnosis documented either bycytology or biopsy.

  • Excluded therapies and medications, previous and concomitant:

  • Any prior systemic anticancer therapy including cytotoxic therapy, targetedagents, experimental therapy, adjuvant, or neo-adjuvant therapy for NSCLC

  • Concomitant use of nephrotoxic drugs, ototoxic drugs, anticonvulsant, anti-gouttreatment

  • Radiotherapy during study or within 3 weeks of start of study drug. (Palliativeradiotherapy will be allowed as described in the Prior and Concomitant Therapysection)

  • Radiotherapy during study or within 4 weeks of start of study drug. (Palliativeradiotherapy will be allowed as described in the Prior and Concomitant Therapysection) (FOR FRANCE ONLY)

  • Major surgery, open biopsy or significant traumatic injury within 4 weeks offirst dose of study drug (bronchoscopy is allowed)

  • Granulocyte colony stimulating factor (GCSF) or Granulocyte macrophage colonystimulating factor (GMCSF), within 3 weeks of study entry (these growth factorsmay be used during the study thereafter).

Study Design

Total Participants: 904
Study Start date:
February 01, 2007
Estimated Completion Date:
June 30, 2011

Study Description

During follow-up, it was determined that there was one additional patient on placebo that was still receiving treatment as of 06 APR 2010 and therefore 10 patients' data are reported in the current CSR addendum, 6 in the sorafenib + GC group and 4 in the placebo + GC group, and as before all in the ITT (non-squamous) population.

Connect with a study center

  • Innsbruck, 6020
    Austria

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  • Linz, 4010
    Austria

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  • Wien, 1130
    Austria

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  • Brasschaat, 2930
    Belgium

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  • Bruxelles - Brussel, 1200
    Belgium

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  • Edegem, 2650
    Belgium

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  • Leuven, 3000
    Belgium

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  • Liege, 4000
    Belgium

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  • Namur, 5000
    Belgium

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  • Salvador, Bahia 40170-070
    Brazil

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    Brasília, Distrito Federal 70840 901
    Brazil

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  • Brasília, Distrito Federal 70840 901
    Brazil

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    Goiânia, Goiás 74075040
    Brazil

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  • Goiania, Goiás 74605-070
    Brazil

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  • Goiânia, Goiás 74075040
    Brazil

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  • Belo Horizonte, Minas Gerais 30110-090
    Brazil

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  • Porto Alegre, Rio Grande do Sul 90610-000
    Brazil

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    Jaú, Sao Paulo 17210-120
    Brazil

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  • Jaú, Sao Paulo 17210-120
    Brazil

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  • Santo Andre, Sao Paulo 09090-780
    Brazil

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    Santo André, Sao Paulo 09060-870
    Brazil

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  • Santo André, Sao Paulo 09060-870
    Brazil

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  • Sorocaba, Sao Paulo 18030-510
    Brazil

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    São Paulo, Sao Paulo 01331020
    Brazil

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  • São Paulo, Sao Paulo 05651-901
    Brazil

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  • Rio de Janeiro, 20231 050
    Brazil

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  • Montreal, Quebec H3A 1A1
    Canada

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  • Guangzhou, Guangdong 510060
    China

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  • Wuhan, Hubei 430030
    China

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  • Nanjing, Jiangsu 210002
    China

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  • Hangzhou, Zhejiang 310022
    China

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  • Beijing, 100021
    China

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  • Shanghai, 200030
    China

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  • Nicosia, 2006
    Cyprus

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  • HUS, 00029
    Finland

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    Preitilä, 21540
    Finland

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  • Preitilä, 21540
    Finland

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  • Tampere, FIN-33521
    Finland

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  • Bayonne, 64100
    France

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  • Grenoble, 38043
    France

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  • Hyeres, 83400
    France

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  • Le Mans Cedex 2, 72015
    France

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  • Marseille, 13275
    France

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  • Nantes, 44805
    France

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  • Nimes Cedex 2, 30907
    France

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  • Paris Cedex 15, 75908
    France

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  • Perpignan, 66000
    France

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  • Pierre Benite, 69495
    France

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  • Strasbourg, 67901
    France

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  • Tours, 37044
    France

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    Löwenstein, Baden-Württemberg 74245
    Germany

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  • Heidelberg, Baden-Württemberg 69126
    Germany

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  • Karlsruhe, Baden-Württemberg 76137
    Germany

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  • Löwenstein, Baden-Württemberg 74245
    Germany

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  • Gauting, Bayern 82131
    Germany

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  • Frankfurt, Hessen 60431
    Germany

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  • Hofheim, Hessen 65719
    Germany

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  • Essen, Nordrhein-Westfalen 45122
    Germany

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    Köln, Nordrhein-Westfalen 51109
    Germany

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  • Köln, Nordrhein-Westfalen 51109
    Germany

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  • Leipzig, Sachsen 04207
    Germany

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    Großhansdorf, Schleswig-Holstein 22927
    Germany

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  • Großhansdorf, Schleswig-Holstein 22927
    Germany

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  • Bad Berka, Thüringen 99437
    Germany

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  • Hamburg, 21075
    Germany

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  • Heraklion, Creta 711 10
    Greece

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  • Athens, 11527
    Greece

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  • Budapest, 1125
    Hungary

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  • Deszk, 6772
    Hungary

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  • Matrahaza, 3233
    Hungary

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  • Szekesfehervar, 8000
    Hungary

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  • Torokbalint, 2045
    Hungary

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  • Ashkelon, 7830604
    Israel

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  • Holon, 58100
    Israel

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  • Kfar Saba, 4428164
    Israel

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  • Rehovot, 7610001
    Israel

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  • Tel Hashomer, 5262000
    Israel

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  • Rozzano, Milano 20089
    Italy

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  • Monza, Monza-Brianza 20052
    Italy

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  • Aviano, Pordenone 33081
    Italy

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  • Bologna, 40138
    Italy

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  • Catania, 95122
    Italy

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  • Firenze, 50134
    Italy

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  • Livorno, 57124
    Italy

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  • Milano, 20132
    Italy

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  • Roma, 00152
    Italy

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  • Sassari, 07100
    Italy

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  • Venezia, 30122
    Italy

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  • Verona, 37134
    Italy

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  • empty

    México, Distrito Federal 14080
    Mexico

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  • México, Distrito Federal 14080
    Mexico

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  • Guadalajara, Jalisco 44280
    Mexico

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  • Monterrey, Nuevo Leon 64460
    Mexico

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  • Den Bosch, 5211 RW
    Netherlands

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  • Ede, 6716 RP
    Netherlands

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  • Harderwijk, 3844 DG
    Netherlands

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  • Heerlen, 6419 PC
    Netherlands

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  • Nieuwegein, 3435 CM
    Netherlands

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  • Terrassa, Barcelona 08227
    Spain

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  • Cruces/Barakaldo, Bilbao 48903
    Spain

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    A Coruña, 15006
    Spain

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  • A Coruña, 15006
    Spain

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  • Barcelona, 08025
    Spain

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  • Madrid, 28041
    Spain

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    Málaga, 29010
    Spain

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  • Málaga, 29010
    Spain

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  • Sevilla, 41013
    Spain

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  • Valencia, 46015
    Spain

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  • Basel, Basel-Stadt 4031
    Switzerland

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    Genéve, Genève 1205
    Switzerland

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  • Genéve, Genève 1205
    Switzerland

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  • Bern, 3010
    Switzerland

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  • Cambridge, Cambridgeshire CB2 0QQ
    United Kingdom

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  • Aberdeen, Grampian AB25 2ZN
    United Kingdom

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  • Leicester, Leicestershire LE1 5WW
    United Kingdom

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  • Sutton, Surrey SM2 5PT
    United Kingdom

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  • Wolverhampton, West Midlands WV10 0QP
    United Kingdom

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  • Birmingham, B15 2TH
    United Kingdom

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  • London, SE1 9RT
    United Kingdom

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