A Randomized Phase 2 Study of Pemetrexed in Combination with Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients with Completely Resected Stage Ib or II Non-Small Cell Lung Cancer - Not available

• Conditions: Patients with histologically proven and completely resected (R0) stage Ib, IIa or IIb non-small cell lung cancer (NSCLC).; MedDRA version: 14.0Level: PTClassification code 10029518Term: Non-small cell lung cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0Level: PTClassification code 10029517Term: Non-small cell lung cancer stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2005-002911-26-DE
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-13
• Last Update Posted: 11 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

[1] Patients with histologically proven and completely resected (R0) stage Ib, IIa or IIb NSCLC.
[2] Complete NSCLC tumor resection (R0) by pneumonectomy or lobectomy (sublobar and wedge resection excluded) with resection of any involved N1 lymph nodes, within 3-6 weeks prior to study enrollment.
[3] Patients must have been surgically proven to be N2 negative.
[4] Performance status of 0 or 1 on the ECOG performance status scale.
[5] No previous antitumor- (chemo-, hormonal-, immuno-) therapy.
[6] No previous antitumor-radiation therapy.
[7] Patients are compliant and live within geographic proximity that allows adequate follow-up.
[8] 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 times the upper limit of normal, alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) <=3.0 x ULN.
Renal: calculated creatinine clearance (CrCl) >= 45 mL/min based on the standard Cockroft and Gault formula.
[9] Signed informed consent document.
[10] At least 18 years of age.
[11] For women: Patients are 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: Patients are 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

[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] Patient has previously completed or withdrawn from this study or any other study investigating pemetrexed.
[14] A serious concomitant systemic disorder (e.g., active infection including HIV) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study.
[15] Any concomitant systemic disorder that prohibits or interferes with the administration of one of the combination drugs (cisplatin and/or carboplatin).
[16] Post-operative complications or other surgery related conditions that could interfere with a study participation.
[17] Unable or unwilling to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures.
[18] A prior malignancy other than NSCLC, except carcinoma in situ of the cervix or non-melanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
[19] A significant cardiovascular disease in terms of an abnormal electrocardiogram (ECG) coupled with clinical signs of recent or recurrent cardiac disease (including myocardial infarction within the last 6 months, angina or uncontrolled hypertension).
[20] Patient is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) for a 5-day period starting 2 days before administration of pemetrexed (8-day period before long-acting agents such as piroxicam).
[21] Clinically significant effusions (pleural or peritoneal) that cannot be drained.
[22] Pregnancy or breast-feeding.
[23] Concurrent administration of any other antitumor therapy.

Study & Design

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