Phase II Study of Concurrent Carboplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer - ND

• Conditions: imited Stage Small Cell Lung Cancer; MedDRA version: 6.1Level: PTClassification code 10041069

• Registration Number: EUCTR2007-000913-13-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

[1] Histologic and/or cytologic diagnosis of LS-SCLC, without cytological proven malignant pleural effusion and confined to 1 hemithorax [2] Performance status of 0 to 1 on the ECOG performance status schedule (Oken et al. 1982)
[3] Measurable disease as defined by: At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST; Therasse et al. 2000) criteria (at least 10 mm in longest diameter by spiral computerized tomography [CT] scan, or at least 20 mm by standard techniques). Positron emission tomography (PET) scans and ultrasounds may not be used.
[4] 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 haemoglobin >=9 g/dL. Hepatic: bilirubin <=1.5 times the upper limit of normal (× ULN); alkaline phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransaminase (ALT) <=3.0 × ULN. Renal: calculated creatinine clearance (CrCl) >=45 mL/min based on the standard Cockcroft and Gault formula
[5] 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] For women: must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device [IUD], birth control pills, or barrier device) during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrolment and must not be breast-feeding. For men: must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after the treatment period.
Are the trial subjects under 18? yes
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

[1] 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. [2] 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 (see Protocol Attachment S095.6 New York Heart Association Classifications). [3] 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.
[4] Have had a recent (within 30 days of study treatment) or concurrent yellow fever vaccination.
[5] 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. [6] Prior chemotherapy for this cancer and/or prior TRT
[7] Pregnancy/breast-feeding.
[8] Significant weight loss (that is >10%) over the previous 6 weeks before study entry.
[9] Concurrent administration of any other anti-tumour therapy.
[120] 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).
[11] Inability or unwillingness to take folic acid or vitamin B12 supplementation.
[12] Inability to take corticosteroids. [13] Completion or withdrawal from this study or any other study investigating pemetrexed, carboplatin, and/or TRT.

Study & Design

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