A randomised Phase 3 Trial of ALIMTA and Cisplatin versus GEMZAR and Cisplatin in Patients with locally advanced or metastatic Non-Small-Cell Lung Cancer

• Conditions: ocally advanced or metastatic Non-Small Cell Lung Cancer

• Registration Number: EUCTR2004-000028-34-ES
• Lead Sponsor: illy S.A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-09
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1700

Inclusion Criteria

Histologic or cytologic diagnosis of NSCLC Stage IIIB or IV
No prior systemic chemotherapy for lung cancer
At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST), longest diameter ,10 mm with spiral computed tomography (CT) scan, or ,20 mm with conventional techniques.Positron emission tomography (PET) scans and ultrasounds should not be used for lesion measurements.
ECOG performance status of 0 or 1
At least 18 years of age
Adequate organ function, including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ³1.5 ´ 109/L, platelets ³100 ´ 109/L, and hemoglobin ³9 g/dL.Hepatic: bilirubin £1.5 times the upper limit of normal (´ ULN), alkaline phosphatase (AP), aspartate transaminase (AST), and alanine transaminase (ALT) £3.0 ´ ULN (AP, AST, and ALT £5 ´ ULN is acceptable if the liver has tumor involvement)
Renal: calculated creatinine clearance (CrCl) ³45 mL/minute based on the standard Cockcroft and Gault formula (Cockcroft and Gault 1976).
Prior radiation therapy allowed to <25% of the bone marrow. Prior radiation to the whole pelvis is not allowed.Prior radiotherapy must be completed at least 4 weeks before study enrolment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrolment.
Estimated life expectancy of > 12 weeks

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Peripheral neuropathy of > CTC grade 1
Serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient’s ability to complete the study.
Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
Documented brain metastatses unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 4 weeks before enrollment. Brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients.
Presence of clinically detectable (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry.
Significant weight loss (that is > 10%) over the previous 6 weeks before study entry.
Concurrent administration of any other antitumor therapy.
Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for 5-day period (8-day period for long-actiong agents, such as piroxicam)
Inability or unwillingness to take folic acid or vitamin B12.
Inability to take corticosteroids

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare ALIMTA plus cisplatin with GEMZAR plus cisplatin in terms of the overall survival of previously untreated patients with Stage IIIB and IV NSCLC.;Secondary Objective: Compare between treatment arm:<br>Time-to-event efficacy variables, including:Progression-free survival, Time to progressive disease, Duration of response, Time to treatment failure<br>Objective tumor response<br>Quantitative and qualitative laboratory and nonlaboratory toxicities<br>Risk/benefit (toxicities relative to survival);Primary end point(s): Overall survival time