Phase I/II Study of Concurrent Cisplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer - N/A

• Conditions: imited Stage Small Cell Lung Cancer; MedDRA version: 8.1Level: LLTClassification code 10041069Term: Small cell lung cancer limited stage

• Registration Number: EUCTR2006-003007-39-BE
• Lead Sponsor: Eli Lilly and Company limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 61

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 < or = 1.5 times the upper limit of normal (x ULN), alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) < or = 3.0 x ULN.
Renal: calculated creatinine clearance (CrCl) =60mL/min based on the standard Cockroft and Gault formula
[6] adequate pulmonary function as defined as a Forced Expiratory Volume in 1 sec (FEV1) > 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

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.

Study & Design

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