TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer
- Conditions
- Carcinoma, Non Small Cell Lung
- Interventions
- Registration Number
- NCT01282151
- Lead Sponsor
- Chonnam National University Hospital
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 148
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Taxotere Taxotere Docetaxel plus Cisplatin Pemetrexed Pemetrexed Pemetrexed plus Cisplatin
- Primary Outcome Measures
Name Time Method Progression Free Survival one year months after beginning of first cycle chemotherapy
- Secondary Outcome Measures
Name Time Method Overall Survival (months from the beginning of first cycle chemotherapy) three years months from the beginning of first cycle chemotherapy
Safety Profile four months Toxicity using CTCAE version 4.0
Response rate 6-7th week Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Trial Locations
- Locations (15)
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Jeonnam, Korea, Republic of
Kyungpook National University Medical Center
🇰🇷Daegu, Kyungpook, Korea, Republic of
Hallym University Medical Center
🇰🇷Anyang, Korea, Republic of
Dankook University Hospital
🇰🇷Cheonan, Korea, Republic of
Keimyung University Dongsan Center
🇰🇷Daegu, Korea, Republic of
Yeungnam Univeristy Hospital
🇰🇷Daegu, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Konkuk university medical center
🇰🇷Seoul, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Pusan, Korea, Republic of
Korea Cancer Center Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Medical Center
🇰🇷Seoul, Korea, Republic of
Wonju Christian Hospital
🇰🇷Wonju, Korea, Republic of