?Pemetrexed with simplified folate and dexamethasone supplementation versus pemetrexed with standard supplementation as second-line chemotherapy for patients with non-small cell lung cancer? - ND

• Conditions: Patients with histological or cytological diagnosis of NSCLC with locally advanced or metastatic disease. Patients must have failed only one prior chemotherapy regimen and must be considered eligible for further chemotherapy following progression of their disease.; MedDRA version: 9.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastatic

• Registration Number: EUCTR2007-004950-10-IT
• Lead Sponsor: ELI LILLY

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-21
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1] Histologic or cytologic diagnosis of NSCLC with locally advanced or metastatic disease (Stage IIIA, IIIB, or IV), as defined by the American Joint Committee on Cancer Staging Criteria for NSCLC (Fleming et al. 1997, Mountain 1997). (See Protocol Attachment S111.1). [2] Patients must have failed only one prior chemotherapy regime and must be considered eligible for further chemotherapy following progression of their disease. The first chemotherapy regime may be administered as neoadjuvant, adjuvant, concurrent with radiotherapy, or palliatively in advanced disease. Chemotherapy must be completed at least 2 weeks prior to randomization and the patient must have recovered from the acute toxic effects of the regimen (except alopecia). [3] Disease status must be that of measurable disease as defined by RECIST criteria (Therasse et al. 2000). [4] Prior radiation therapy is allowed, but should be limited to <25% of the bone marrow (Cristy and Eckerman 1987). Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks prior to randomization. Patients must have recovered from the acute toxic effects of the treatment prior to randomization. [5] Prior surgery is allowed, but should be completed at least 4 weeks prior to randomization, and, in the opinion of the investigator, the patient must have recovered from the surgery. Patients who, in the opinion of the investigator, have fully recovered from surgery in less than 4 weeks may also be considered for the study. [6] Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Scale. (See Protocol Attachment S111.2) [7] Estimated life expectancy of at least 8 weeks. [8] Patient compliance and geographic proximity that allow adequate follow-up. [9] Adequate organ function including the following: Adequate bone marrow reserve: Absolute neutrophil (segmented and bands) count (ANC) ≥1.5 x 109/L, platelets ≥100 x 109/L, and hemoglobin ≥9 g/dL. Hepatic: Bilirubin ≤1.5 x upper limit of normal (ULN), alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 x ULN (AP, AST and ALT ≤5 x ULN is acceptable if liver has tumor involvement). Renal: Calculated creatinine clearance (CrCl) ≥45 mL/min based on the standard Cockcroft and Gault formula (Protocol Attachment S111.3) [10] Males or females at least 18 years of age. [11] Signed informed consent from patient. [12] Male and female patients with reproductive potential must use an approved contraceptive method if appropriate (e.g., intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study randomization and must not be breast-feeding.
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

[13] Brain metastasis. Patients who are symptomatic for brain metastasis must have a pretreatment computed tomography (CT) scan or magnetic resonance imaging (MRI) of the brain. A patient with documented brain metastasis at the time of randomization will be excluded. Treated, stable central nervous system metastases are allowed, however, the patient must be stable after radiotherapy for ≥2 weeks and off all corticosteroids or on a stable dose for ≥1 week. [14] Prior exposure to agents directed at pemetrexed molecular targets (such as thymidylate synthase or dihydrofolate reductase inhibitors). [15] Concurrent administration of any other antitumor therapy. [16] 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. [17] Active infection that in the opinion of the investigator would compromise the patient?s ability to tolerate therapy. [18] Serious concomitant disorders that would compromise the safety of the patient or compromise the patient?s ability to complete the study, at the discretion of the investigator. [19] Pregnancy or breast-feeding. [20] Have had a prior malignancy other than NSCLC, 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. [21] Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents, other than aspirin doses ≤1.3 grams per day, for a 5-day period (8-day period for long-acting agents such as piroxicam). [22] Presence of clinically relevant (by physical exam) third-space fluid collections (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry. [23] Inability or unwillingness to take folic acid or vitamin B12 supplementation or dexamethasone (or equivalent). [24] Significant weight loss (i.e., ≥10%) over the 6 weeks before study entry.

Study & Design

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