A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin can reduce tumor size.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Cisplatin; Dexamethasone; Folic Acid; Hydroxocobalamin; Pemetrexed; Vitamin B 12

Criteria

Inclusion Criteria:

• Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy

• Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)

• Tumor considered potentially resectable

• Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology Group scale (ECOG)

• No prior therapy for lung cancer

• Measurable disease according to version 1.1 of Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

• Life expectancy of at least 6 months

• Organs are functioning well (bone marrow reserve, liver, kidney, lung)

• Signed Informed Consent

• Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after last dose of study drug; must have a negative pregnancy test within 7 days before study enrollment; and must not be breast-feeding.

• Men must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after last dose of study drug.

• Be fit for surgery at the time of enrollment

Exclusion Criteria:

• Receiving or have received an investigational drug or device within the last 30 days

• Have previously completed or withdrawn from this study or any other study investigating pemetrexed

• Serious concomitant systemic disorder

• Serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease

• Receiving concurrent administration of any other anticancer therapy

• Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination

• Inability or unwillingness to take Pemetrexed supplementation/premedication (folic acid, vitamin B12, or corticosteroids)

• Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose less than or equal to 1.3 grams per day