Status:
COMPLETED
Gefitinib With or Without Simvastatin in Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The epidermal growth factor receptor (EGFR) is a key regulator of growth, differentiation, and survival of epithelial cancers. In a small subset of tumors, the presence of activating mutations within ...
Detailed Description
Randomization 1. Sex (female vs. male) 2. ECOG PS (0/1 vs. 2/3) 3. Number of prior regimen (one vs. two). Gefitinib (250 mg per day) + Simvastatin (40 mg per day) PO or Gefitinib (250 mg per day) al...
Eligibility Criteria
Inclusion
- Histologic or cytologic diagnosis of NSCLC
- Stage IV or selected stage IIIB (with positive pleural effusion or multiple ipsilateral lung nodules) according to the American Joint Committee on Cancer (AJCC).
- Previously treated with at least one platinum-based chemotherapy.
- Before study entry, a minimum of 21 days must have elapsed since any prior chemotherapy.
- Prior radiation therapy is allowed as long as the irradiated area is not the only source of measurable disease.
- No other forms of cancer therapy, such as radiation, immunotherapy for at least 2 weeks before the enrollment in study.
- Performance status of 0-3 on the ECOG criteria.
- At least one unidimensional measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST. 2000).- Estimated life expectancy of at least 8 weeks.
- Patient compliance that allow adequate follow-up.
- Adequate hematologic (ANC count ≥ 1,000/uL, platelet count ≥ 150,000/mm3), hepatic (bilirubin level≤1.5 mg/dL, AST/ALT ≤ 80 IU/L), and renal (creatinine concentration ≤ 1.5 mg/dL) function.
- Informed consent from patient or patient's relative.
- Males or females at least 18 years of age.
- If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after trial. If male, use of an approved contraceptive method during the study and 3 months afterwards. Females with childbearing potential must have a urine negative hCG test within 7 days prior to the study enrollment.
- No concomitant prescriptions including cyclosporin A, valproic acid, phenobarbital, phenytoin, ketoconazole.
- Patients with brain metastasis are allowed unless there were clinically significant neurological symptoms or signs
Exclusion
- Presence of small-cell lung cancer alone or with NSCLC- Unresolved chronic toxic effects from previous anticancer therapy
- Known severe hypersensitivity to gefitinib or any of the tablet excipients
- Inability to swallow tablets
- Other coexisting malignant disease (apart from basal-cell carcinoma)
- More than three previous chemotherapy regimens for NSCLC
- Previous treatment with an experimental agent of which the main mechanism of action is inhibition of epidermal growth factor receptor or its associated tyrosine kinase
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's wort; severe or uncontrolled systemic disease; clinically active interstitial lung disease (except uncomplicated lymphangitic carcinomatosis) pregnancy; and breastfeeding.
- MI within preceding 6 months or symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia
- Serious concomitant infection including post obstructive pneumonia
- Major surgery other than biopsy within the past two weeks.
- Pregnant or breast-feeding.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00452244
Start Date
May 1 2006
End Date
March 1 2011
Last Update
August 25 2017
Active Locations (1)
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1
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, South Korea