Clinical trial NCT01066195: Pemetrexed (ALIMTA) and Gefitinib (IRESSA®) in Never-Smoker and Adenocarcinoma Patients With Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
Official title: A Phase III, Multi-center, Randomized Trial of Pemetrexed and Gefitinib in Never-smoker and Adenocarcinoma Patients With Non-small Cell Lung Cancer Previously Treated With Platinum-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Non-small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Never-Smoker and Adenocarcinoma patients
Pemetrexed (ALIMTA)
Gefitinib (IRESSA®)
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2010-02-10
Enrollment: 129
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: 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.


Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed pulmonary adenocarcinoma including bronchioloalveolar, but except adenosquamous cell carcinoma
2. Stage IIIB (malignant pleural effusion and/or pleural seeding), stage IV and relapsed non-small cell lung cancer
3. Failed with 1st line platinum-based chemotherapy or relapsed within 12 months after adjuvant platinum-based chemotherapy)
4. Never smoker (less than 100 cigarette for the life time)
5. 18 year or older
6. ECOG 0-2
7. No history of biologic or immunotherapy
8. Tolerable renal function ( creatine clearance rate is 60ml/min or more)
9. Tolerable hepatic function (Serum bilirubin ≤ 1.25 x UNL, AST (SGOT) and ALT (SGPT) ≤ 2.5 x UNL, alkaline phosphatase ≤5 x UNL)

Exclusion Criteria:

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

Primary outcomes:
measure: progression-free survival
timeFrame: 36 months
Secondary outcomes:
measure: overall survival
timeFrame: 36 months
measure: objective response rate
timeFrame: 36 months
measure: toxicity
timeFrame: 36 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Myungju Ahn, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References: