advanced NSCLC of Stage IIIb or IV undergoing first line chemotherapy
Conditions
Interventions
Trade Name: Alimta 500mg
Product Name: Alimta 500 mg
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Pemetrexed
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
Lilly Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Cytologically and/or histologically confirmed NSCLC Stage IIIb or IV according to Protocol Attachment S109.3, American Joint Committee on Cancer Staging Criteria for Lung Cancer (Fleming et al. 1997). [2] No previous systemic chemotherapy for this cancer. Previous adjuvant therapy is allowed if it has been more than one year since the end of adjuvant therapy. [3] At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST; Therasse et al. 2000), at least 10 mm in longest diameter with spiral computed tomography (CT) scan, or at least 20 mm with conventional techniques. Positron emission tomography (PET) scans and ultrasounds may not be used. [4] ECOG Performance status of 0 or 1 (Protocol Attachment S109.4). [5] Adequate organ function including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ?1.5 ? 109/L, platelets ?100 ? 109/L, and hemoglobin ?9 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. Exception: AP, AST, ALT ??.0 ? ULN is acceptable only in case of tumor involvement of the liver. Renal: calculated creatinine clearance (CrCl) ? 45 mL/min based on the standard Cockroft and Gault formula (Protocol Attachment S109.5). [6] Prior radiation therapy allowed but limited to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [12] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. [13] Have previously completed or withdrawn from this study or any other study investigating pemetrexed. [14] Have a serious concomitant systemic disorder (eg, active infection including HIV, or cardiac disease) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study. [15] Have an active infection (=38.5ºC fever and/or receiving intravenous antibiotic therapy). [16] A significant cardiovascular disease in terms of an abnormal electrocardiogram (ECG) coupled with clinical signs of recent or recurrent cardiac disease (including myocardial infarction within the last 6 months, angina or uncontrolled hypertension), or heart disease as defined by the New York Heart Association Class III or IV. [17] Patient with mild to moderate renal insufficiency who are unable to interrupt salicylates (like aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period starting 2 days before administration of pemetrexed (8-day period for long-acting agents such as piroxicam). Exception: Low dose aspirin (acetyl salicylic acid) intake up to 150 mg per day is permitted without interruption. For details regarding concomitant therapy with NSAIDs and aspirin refer to Section 5.7.2 . [18] A second primary malignancy that is clinically detectable at the time of consideration for study enrollment. [19] Any symptomatic central nervous system (CNS) metastases requiring concurrent corticosteroid therapy. Treated stable CNS metastases are allowed; the patient must be stable after radiotherapy for =2 weeks and off corticosteroids for =1 week. [20] Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures. [21] Significant weight loss (that is, =10%) over the 6 week period prior to study entry. [22] Concurrent administration of any other antitumor therapy. [23] Have had recent (within 30 days of study treatment) or concurrent yellow fever vaccination. [24] Inability or unwillingness to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures. [25] Pregnant or breast feading
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the progression free survival (PFS) in patients with advanced NSCLC of Stage IIIb or IV undergoing first line chemotherapy with pemetrexed in combination with cisplatin or carboplatin. Patients will be randomized to one of the above regimens in a 1:1 ratio. ;Secondary Objective: to assess the following parameters of either treatment arm: • Overall survival including 1-year survival rate • Objective response rate (according to RECIST criteria) • Time to treatment failure • To characterize the quantitative and qualitative potential toxicities, and the necessity of dose reductions and cycle delays due to toxicities of both treatment regimens. ;Primary end point(s): progression free survival (PFS) | — |
Countries
Germany
Outcome results
None listed