Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC

Gruppo Oncologico Italiano di Ricerca Clinica

Status and phase

Unknown

Phase 2

Conditions

Advanced Non-Small Cell Lung Cancer

Treatments

Drug: Pemetrexed

Drug: Pemetrexed plus carboplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00786331

EudraCT number 2006-004009-24

GOIRC 02/2006

Details and patient eligibility

About

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.

Full description

In spite of the superiority of single agent over best supportive care in second-line NSCLC, the prognosis of these patients remains poor with a median survival of 6-7 months, justifying the evaluation of new regimens in this setting. An open question in the second-line treatment of NSCLC remains the possible superiority of combination chemotherapy over single agent, as it has been clearly demonstrated in first-line. Particularly, the addition of platinum to either docetaxel or pemetrexed should be further investigated especially in patients with prior response/stable disease to platinum-based first-line chemotherapy. Pemetrexed has shown anti-tumor activity in combination with other chemotherapy agents, including gemcitabine, vinorelbine, taxanes, cisplatin and carboplatin. In this multicenter, open label, randomized phase II trial, pemetrexed 500 mg/m2 and carboplatin AUC 5 will be administered on day 1 every 3 weeks until progression of disease or for a maximum of 4 courses in the experimental arm. The control arm will be pemetrexed as single agent at 500 mg/m2 on day 1 every 3 weeks until progression of disease or for a maximum of 4 courses.

Enrollment

230 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.