Status:
COMPLETED
Alimta and Gemcitabine in Non-Small Cell Lung Cancer
Lead Sponsor:
Southern Italy Cooperative Oncology Group
Conditions:
Non-Small Cell Lung Cancer
Stage IIIB or IV
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of a randomized t...
Detailed Description
Patients with stage IIIB or IV non-small cell lung cancer will be randomly allocated to receive: (a)PG regimen: paclitaxel 120 mg/sqm followed by gemcitabine 1,000 mg/sqm i.v. on days 1 \& 8 q 3 weeks...
Eligibility Criteria
Inclusion
- Patients with histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) NSCLC
- No previous adjuvant or palliative chemotherapy
- No previous radiotherapy
- Presence of at least one unidimensionally measurable lesion (Appendix 2)
- ECOG performance status of 0 or 1 (Appendix 3)
- Charlson score ≤ 2 (Appendix 4)
- Adequate bone marrow function (absolute neutrophil count ≥ 2 x 109/L, platelet count ≥ 100 x 109/L, and hemoglobin level ≥ 100 g/L), and adequate liver function (bilirubin level \< two times the upper limit of normal, AST and/or ALT \< three times the upper limit of normal, prothrombin time \< 1.5 times control), and creatinine clearance ≥ 60 ml/min.
- Absence of symptomatic CNS metastases (patients with cerebral metastases treated with brain irradiation may be included), severe cardiac arrhythmia or heart failure, second or third degree heart block or acute myocardial infarction within 4 months prior to study entry.
- No major surgery or pleurodesis within 14 days prior to enrollment.
- Life expectancy of at least 12 weeks.
- No previous or concurrent malignancy, except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease-free for more than 5 years.
- Written informed consent
Exclusion
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, serious cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
- Patients with clinically significant effusions.
- Any other malignancies within 5 years that could affect therapy evaluation
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00434135
Start Date
May 1 2006
End Date
October 1 2008
Last Update
February 5 2009
Active Locations (1)
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1
National Tumor Institute
Naples, Italy, 80131