Clinical trial NCT01282151: TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
Official title: A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Non Small Cell Lung
Keywords: NSCLC
Non Squamous cell
Docetaxel
Pemetrexed
Lead sponsor: Chonnam National University Hospital
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2011-01-24
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is:

* 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.

Detailed description: Docetaxel is being used in 60mg/m2 3 weekly dosage in Japan and several east Asian institutions. Docetaxel 60mg/m2 and Cisplatin 70 mg/m3 3 weekly regimen will be compared to Pemetrexed 500mg/m2 and Cisplatin 70 mg/m2 3 weekly regimen in first line NSCLC with non-squamous histology.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years old
* 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:

* Pregnancy, Lactating woman
* 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)

Primary outcomes:
measure: Progression Free Survival
timeFrame: one year
Secondary outcomes:
measure: Overall Survival (months from the beginning of first cycle chemotherapy)
timeFrame: three years
measure: Safety Profile
timeFrame: four months
measure: Response rate
timeFrame: 6-7th week
Other outcomes:
Locations:
city: Hwasun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
state: Jeonnam
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
state: Kyungpook
city: Anyang
country: Korea, Republic of
facility: Hallym University Medical Center
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Center
city: Daegu
country: Korea, Republic of
facility: Yeungnam Univeristy Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Pusan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk university medical center
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
Study officials:
affiliation: Chonnam National University Hospital
name: Young-Chul Kim, MD, PhD
role: STUDY_CHAIR
References: