Limited Stage Small Cell Lung Cancer MedDRA version: 8.1 Level: LLT Classification code 10041069 Term: Small cell lung cancer limited stage
Conditions
Sponsors
Eli Lilly and Company limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients may be included in the study only if they meet all of the following criteria: [1] Histologic and/or [cytologic] diagnosis of LS-SCLC, without cytological proven malignant pleural effusion and confined to one hemithorax as defined by the IASLC 1989 criteria ( [2] Performance status of 0 to 1 on the ECOG performance status schedule [3] no prior chemo- and/ or prior thoracic radiotherapy [4] Measurable disease defined by: • At least one unidimensionally measurable lesion meeting RECIST criteria [5] adequate organ function including the following: Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.5 x10e9/L, platelets =100 x10e9/L, and hemoglobin =9 g/dL. Hepatic: bilirubin 30% predicted normal value and diffusion capacity (DLCO) > 40% predicted normal value. [7] unlikely to be at excessive risk for radiation pneumonitis as defined by a V20 of =36% and able to drain 3rd space fluids [8] Patient compliance and geographic proximity that allow adequate follow-up. [9] Patients must sign an informed consent document. [10] Patients must be at least 18 years of age. [11] For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after the treatment period; must have a negative serum or urine pregnancy test and must not be lactating. For men: Must be surgically sterile, or compliant with a contraceptive regimen during and for 3 months after the treatment period. 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
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: [12] 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] Completion or withdrawal from this study or any other study investigating pemetrexed. [14] Patients with myocardial infarction within the preceding six months or symptomatic heart disease, including angina, congestive heart failure, or uncontrolled arrhythmia. [15] Diagnosis of a serious concomitant systemic disorder (for example, active infection including HIV) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study. [16] Prior radiotherapy to the lower neck or abdominal region. [17] Discovery of a second primary malignancy that is clinically detectable at the time of consideration for study enrollment. [18] Significant weight loss (that is, U>10%) over the previous 6 weeks before study entry. [19] Concurrent administration of any other antitumour therapy. [20] 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). [21] Inability or unwillingness to take folic acid or vitamin B12 supplementation. [22] Inability to take corticosteroids. [23] Inability to comply with protocol or study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the phase I part of this study is to determine the recommended Phase 2 dose of pemetrexed, cisplatin, and involved-field radiotherapy in the treatment of patients with LS-SCLC. The primary objective of the phase II part of this study is to further delineate the activity of this regimen at the recommended dose in terms of overall response rate ;Secondary Objective: Secondary objectives: • to determine the maximum tolerated dose of pemetrexed, cisplatin and involved-field radiotherapy. •to determine the quantitative and qualitative dose-limiting toxicities of pemetrexed in combination with cisplatin and curative thoracic radiation therapy in this patient population. • further characterization of acute and late toxicities • to document objective best overall response Phase II: Secondary objectives of the study include the following: • further characterization of acute and late toxicities, • to determine complete response rate • to assess time-to-event: - Time to progressive disease - Duration of Response - Overall Survival.;Primary end point(s): The primary endpoint for Phase I is the determination of the recommended Phase II dose of pemetrexed, cisplatin, and involved-field radiotherapy for subsequent evaluation in the treatment of patients with LS-SCLC. The primary endpoint for Phase II is to further delineate the activity of this regimen at the recommended dose in terms of overall response rate. | — |
Countries
Belgium, Netherlands
Outcome results
None listed