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

NCT01282151 | Terminated Phase 3 DMC

• 1 other identifier: DOCET_L_05478
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 15

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.

Conditions

Carcinoma, Non Small Cell Lung

Keywords

NSCLC; Non Squamous cell; Docetaxel; Pemetrexed

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  months after beginning of first cycle chemotherapy

  one year

Secondary Outcomes (3)

• Overall Survival (months from the beginning of first cycle chemotherapy)

  three years

• Safety Profile

  four months

• Response rate

  6-7th week

Study Arms (2)

Taxotere

EXPERIMENTAL

Docetaxel plus Cisplatin

Drug: Taxotere

Pemetrexed

ACTIVE COMPARATOR

Pemetrexed plus Cisplatin

Drug: Pemetrexed

Interventions

Taxotere DRUG

Docetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks

Also known as: Taxotere(R), Cisplatin

Taxotere

Pemetrexed DRUG

Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks

Also known as: Alimta (R), Cisplatin

Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chonnam National University Hospital: lead
• Sanofi: collaborator

Study Sites (15)

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, 519-709, South Korea

Location

Kyungpook National University Medical Center

Daegu, Kyungpook, South Korea

Location

Hallym University Medical Center

Anyang, South Korea

Location

Dankook University Hospital

Cheonan, 330-715, South Korea

Location

Keimyung University Dongsan Center

Daegu, 700-712, South Korea

Location

Yeungnam Univeristy Hospital

Daegu, South Korea

Location

Chosun University Hospital

Gwangju, South Korea

Location

Wonkwang University Hospital

Iksan, South Korea

Location

Inha University Hospital

Incheon, South Korea

Location

Pusan National University Hospital

Pusan, 602-739, South Korea

Location

Kosin University Gospel Hospital

Pusan, South Korea

Location

Konkuk university medical center

Seoul, 143-729, South Korea

Location

Korea Cancer Center Hospital

Seoul, South Korea

Location

Korea University Medical Center

Seoul, South Korea

Location

Wonju Christian Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Cisplatin; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Young-Chul Kim, MD, PhD

  Chonnam National University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 24, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: July 14, 2015

Record last verified: 2015-07

Locations

KR (15)