TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
NCT ID: NCT01282151
Last Updated: 2015-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
148 participants
INTERVENTIONAL
2011-07-31
2014-12-31
Brief Summary
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* A multicenter, prospective, randomized, phase 3 trial.
* To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a front line treatment of patients with non-squamous cell lung cancer.
* 276 patients will be recruited.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Taxotere
Docetaxel plus Cisplatin
Taxotere
Docetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
Pemetrexed
Pemetrexed plus Cisplatin
Pemetrexed
Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
Interventions
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Taxotere
Docetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
Pemetrexed
Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG performance status 0-2
* Non-squamous cell type non-small cell lung cancer (NSCLC)
* Stage IV, Stage IIIB cannot be treated with curative intent or Relapsed after surgery or radiation therapy
* No prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation treatment. The last dose of adjuvant chemotherapy should be at least 6 months earlier from randomization, and the regimen should not contain docetaxel or pemetrexed.
* No prior immunotherapy, biologic therapy
* Measurable lesion with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Hemoglobin \>=9.0g/dl, Platelet \>=100,000/uL, neutrophil \>=1,500 /uL Creatinine \<=1.5 x upper normal limit or creatinine clearance \>=60 mL/min Bilirubin \<=1.5 x upper normal limit, Transaminases \<=2 x upper normal limit Alkaline phosphatase \<=2 x upper normal limit
* Written informed consent
Exclusion Criteria
* Woman in child bearing age who refuses to do pregnancy test
* Moderate or greater than grade 1 motor or sensory neurotoxicity
* Hypersensitivity to taxane
* Comorbidity or poor medical conditions
* Other malignancy (except cured basal cell carcinoma or uterine cervical carcinoma in situ)
* Concurrent treatment with other investigational drugs within 30 days before randomization
* Active treatment with other anticancer chemotherapy
* EGFR mutation (exon 19 deletion, L858R, L861Q, G719A/C/S)
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Chonnam National University Hospital
OTHER
Responsible Party
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Young-Chul Kim
Professor
Principal Investigators
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Young-Chul Kim, MD, PhD
Role: STUDY_CHAIR
Chonnam National University Hospital
Locations
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Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, South Korea
Kyungpook National University Medical Center
Daegu, Kyungpook, South Korea
Hallym University Medical Center
Anyang, , South Korea
Dankook University Hospital
Cheonan, , South Korea
Keimyung University Dongsan Center
Daegu, , South Korea
Yeungnam Univeristy Hospital
Daegu, , South Korea
Chosun University Hospital
Gwangju, , South Korea
Wonkwang University Hospital
Iksan, , South Korea
Inha University Hospital
Incheon, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Kosin University Gospel Hospital
Pusan, , South Korea
Konkuk university medical center
Seoul, , South Korea
Korea Cancer Center Hospital
Seoul, , South Korea
Korea University Medical Center
Seoul, , South Korea
Wonju Christian Hospital
Wŏnju, , South Korea
Countries
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Other Identifiers
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DOCET_L_05478
Identifier Type: -
Identifier Source: org_study_id
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