Pemetrexed (ALIMTA) and Gefitinib (IRESSA®) in Never-Smoker and Adenocarcinoma Patients With Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

NCT01066195 | Unknown Phase 3

• 1 other identifier: 2008-04-030
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Pemetrexed was known to be effective to pulmonary adenocarcinoma and gefitinib was known to be more effective to non-small cell lung cancer (NSCLC) patients with clinical characteristics such as adenocarcinoma, never smoker and female. The investigators try to evaluate which drug (pemetrexed vs gefitinib) is more efficious to NSCLC patients with clinical characteristics such as adenocarcinoma and never smoking history as second- or further-line therapy.

Conditions

Non-small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; Never-Smoker and Adenocarcinoma patients; Pemetrexed (ALIMTA); Gefitinib (IRESSA®)

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  36 months

Secondary Outcomes (3)

• overall survival

  36 months

• objective response rate

  36 months

• toxicity

  36 months

Study Arms (2)

gefitinib

EXPERIMENTAL

Drug: iressa

pemetrexed

ACTIVE COMPARATOR

Drug: alimta

Interventions

iressa DRUG

iressa 250mg per day every day

gefitinib

alimta DRUG

alimta 500mg/m2 every 3 weeks

pemetrexed

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed pulmonary adenocarcinoma including bronchioloalveolar, but except adenosquamous cell carcinoma
• Stage IIIB (malignant pleural effusion and/or pleural seeding), stage IV and relapsed non-small cell lung cancer
• Failed with 1st line platinum-based chemotherapy or relapsed within 12 months after adjuvant platinum-based chemotherapy)
• Never smoker (less than 100 cigarette for the life time)
• year or older
• ECOG 0-2
• No history of biologic or immunotherapy
• Tolerable renal function ( creatine clearance rate is 60ml/min or more)
• Tolerable hepatic function (Serum bilirubin ≤ 1.25 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤5 x UNL)

You may not qualify if:

• symptomatic brain metastasis
• previously treated with EGFR tyrosine kinase inhibitor
• previously treated with antifolate agents
• poor oral absorption
• patients with active infection
• uncontrolled diabetes mellitus
• significant cardiovascular disease (uncontrolled hypertension, history of myocardial infarction or unstable angina within 6 months, congestive heart failure)
• pregnant or nursing patients
• history of malignant disease within 3 years before the enrollment except for cured non-melanomatous skin cancer, cervical carcinoma in situ, or thyroid carcinoma

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gefitinib; 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)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Myungju Ahn, Ph.D., M.D.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 10, 2010
• Study Start: May 1, 2008
• Primary Completion: October 1, 2010
• Last Updated: February 10, 2010

Record last verified: 2010-02

Locations

KR (1)