Previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). MedDRA version: 9.1 Level: LLT Classification code 10059515 Term: Non-small cell lung cancer metastatic
Conditions
Interventions
Trade Name: ALIMTA
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Pemetrexed
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade Name: CARBO
Sponsors
GRUPPO ONCOLOGICO ITALIANO DI RICERCA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient must give written (personally signed and dated) informed consent before completing any study related procedure. Males or females >=18 years. Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC). 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 = 12 weeks. Adequate hematological, hepatic and renal functions. Prior treatment with only 1 chemotherapy regimen for the treatment of advanced disease which should have included a platinum agent (prior treatment with gefitinib/erlotinib as maintenance after 1st line chemotherapy is allowed and not considered as a chemotherapy regimen). At least 4 weeks from prior chemotherapy with complete recovery from first line chemotherapy side effects to =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior treatment with pemetrexed. Patients who are:pregnant or lactating;at risk of pregnancy during the study. This must be checked by pregnancy test at study entry. The patient must be receiving a medically accepted contraceptive regimen. Patients with any underlying medical condition that might be aggravated by treatment or which cannot be controlled. Documented brain metastases unless the patient has completed local therapy for central nervous system metastases and has been off corticosteroids for at least two weeks before enrollment. History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix. Treatment with any investigational drug within the 30 days prior to registration. Concomitant treatment with any other anticancer drug. Known hypersensitivity to the study drugs or to drugs with similar chemical structures. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents 2 days before, the day of, and 2 days after the dose of pemetrexed single agent or pemetrexed plus carboplatin. If a patient is taking an NSAID (COX-2 inhibitors included) or salicylate with a long half-life (for example, naproxen, piroxicam, diflunisal, nabumetone, rofecoxib or celecoxib) it should not be taken 5 days before the dose of pemetrexed (8-day period for long-acting agents such as piroxicam), the day of, and 2 days after the dose of pemetrexed single agent or pemetrexed plus carboplatin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC.;Secondary Objective: To assess differences in terms of response rate between the combination pemetrexed-carboplatin and pemetrexed alone. To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone. To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone. To assess differences in terms of survival between the combination pemetrexed-carboplatin and pemetrexed alone.;Primary end point(s): To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC | — |
Countries
Italy
Outcome results
None listed