TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer

Carcinoma, Non Small Cell Lung Clinical Trial

— TRAIL  

Official title:

A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01282151
• Other study ID #: DOCET_L_05478
• Status: Terminated
• Phase: Phase 3
• First received: January 21, 2011
• Last updated: July 13, 2015
• Start date: July 2011
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Chonnam National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 148
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non Small Cell Lung
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• 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

Locations

Country	Name	City	State
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	Kyungpook National University Medical Center	Daegu	Kyungpook
Korea, Republic of	Yeungnam Univeristy Hospital	Daegu
Korea, Republic of	Chosun University Hospital	Gwangju
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeonnam
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Kosin University Gospel Hospital	Pusan
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Konkuk university medical center	Seoul
Korea, Republic of	Korea Cancer Center Hospital	Seoul
Korea, Republic of	Korea University Medical Center	Seoul
Korea, Republic of	Wonju Christian Hospital	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
Chonnam National University Hospital	Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	months after beginning of first cycle chemotherapy	one year
Secondary	Overall Survival (months from the beginning of first cycle chemotherapy)	months from the beginning of first cycle chemotherapy	three years
Secondary	Safety Profile	Toxicity using CTCAE version 4.0	four months
Secondary	Response rate	Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1	6-7th week