Extensive stage Disease Small cell Lung cancer
Conditions
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: [1] Histological or cytological diagnosis of ED-SCLC, including malignant pleural effusion (see Protocol Attachment JMHO.4 Staging of Small Cell Carcinoma of Lung). [2] Performance status of 0 to 2 on the ECOG performance status schedule (Oken et al. 1982). (See Protocol Attachment JMHO.3) [3] No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC. [4] Prior radiation therapy allowed to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following 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 participated in a study involving pemetrexed. [14] Have a mixed histological diagnosis of SCLC and NSCLC. [15] Have a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient’s ability to adhere to the protocol. [16] Have an active infection (=38.5ºC and/or receiving intravenous antibiotic therapy). [17] Have a 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 (Protocol Attachment JMHO.8). [18] Have had recent (within 30 days of study treatment) or concurrent yellow fever vaccination. [19] Have had a prior malignancy other than SCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score =6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously. [20] Symptomatic central nervous system (CNS) metastases and asymptomatic CNS metastases requiring concurrent corticosteroid therapy. Treated stable CNS metastases are allowed; the patient must be stable after radiotherapy for =2 weeks and off of corticosteroids for =1 week. [21] Presence of clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. [22] Significant weight loss (that is, =10%) over the 6 week period prior to study entry. [23] Concurrent administration of any other antitumor therapy. [24] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose =1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam). [25] Inability or unwillingness to take folic acid or vitamin B12 supplementation. [26] Inability to take corticosteroids.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the overall survival of previously untreated patients with ED-SCLC after treatment with pemetrexed plus carboplatin versus etoposide plus carboplatin.;Secondary Objective: The secondary objectives of the study are to assess and compare the following variables between treatment arms: • overall survival among a subgroup of patients classified as “sensitive” with respect to the results of a prospectively defined set of biomolecular assays • time-to-event variables, including: o objective progression-free survival (PFS) o survival without Grade 4 toxicity (G4 SWT) o survival without Grade 3-4 toxicity (G3-4 SWT) o time to worsening of HRQoL (health-related quality of life) (TWQ) • objective tumor response • time-to-event variables and objective tumor response among the subgroup of patients classified as “sensitive” with respect to the results of a prospectively defined set of biomolecular assays • changes in dimensions of HRQoL • the safety and adverse event profile (including Common Terminology Criteria for Adverse Events [CTCAE Version 3.0, NCI 2003] grades for laboratory and nonlaboratory adverse events) ;Primary end point(s): The primary endpoint of this study is to compare pemetrexed plus carboplatin with etoposide plus carboplatin in terms of overall survival (OS) of previously untreated patients with ED-SCLC | — |
Countries
Austria, Belgium, Germany, Greece, Hungary, Italy, Netherlands, Portugal, Spain, United Kingdom
Outcome results
None listed