Randomized phase II study of pemetrexed versus pemetrexed and carboplatin as second line chemotherapy in advanced non-small-cell lung cancer (NSCLC). - ND
- Conditions
- Previously treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).MedDRA version: 9.1Level: LLTClassification code 10059515Term: Non-small cell lung cancer metastatic
- Registration Number
- EUCTR2006-004009-24-IT
- Lead Sponsor
- GRUPPO ONCOLOGICO ITALIANO DI RICERCA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 <=2.
Life expectancy >= 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 < Grade 2.
Prior radiotherapy allowed, only in case of presence of at least one measurable lesion outside an irradiated area. Radiotherapy must have been completed at least 2 weeks before registration.
At baseline, presence of at least one measurable target lesion according to RECIST criteria. All radiology studies must be performed within 28 days prior to randomization.
Absence of any psychological, familial, sociological or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br><br>To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone.<br><br>To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone.<br><br>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
- Secondary Outcome Measures
Name Time Method