Overview

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.