Advanced Non-Small Cell Lung Cancer
Conditions
Keywords
second line treatment, pemetrexed, carboplatin
Brief 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.
Detailed 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.
Interventions
DRUGPemetrexed
Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 of a 21 days cycle
Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 and Carboplatin AUC 5 i.v. over approximately 30 minutes on day 1 (beginning approximately 30 minutes after the end of the pemetrexed infusion) of a 21 days cycle
Sponsors
Gruppo Oncologico Italiano di Ricerca Clinica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC | 36 months |
Secondary
| Measure | Time frame |
|---|---|
| To assess differences in terms of response rate between the combination pemetrexed-carboplatin and pemetrexed alone. | 3 months |
| To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone. | 36 months |
| To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone. | 3 months |
| To assess differences in terms of survival between the combination pemetrexed-carboplatin and pemetrexed alone. | 36 months |
Countries
Italy
Contacts
Primary ContactLuca Boni, MD
Outcome results
None listed