Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC.

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

Details

• Lead Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica
• Treatments: Carboplatin; Pemetrexed

Criteria

Inclusion Criteria:

• written informed consent

• Histologically or cytologically confirmed non-small-cell lung cancer

• Unresectable stage IIIB, stage IV and unresectable local relapse or metastatic disease, with evidence of disease progression after first line chemotherapy which should have included a platinum agent.

• ECOG performance status lower than or equal to 2

• Adequate hematological, hepatic and renal functions

• Life expectancy greater than or equal to 12 weeks

• Prior treatment with only 1 chemotherapy regimen for the treatment of advanced disease which should have included a platinum agent

• At baseline, presence of at least one measurable target lesion as per RECIST criteria

Exclusion Criteria:

• Prior treatment with pemetrexed.

• Patients who are pregnant or lactating

• Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled.

• Symptomatic brain metastases

• History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix.

• Concomitant treatment with any other anticancer drug.