Status:
UNKNOWN
Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC
Lead Sponsor:
Gruppo Oncologico Italiano di Ricerca Clinica
Conditions:
Advanced Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00786331
Start Date
July 1 2007
End Date
December 1 2009
Last Update
August 3 2009
Active Locations (21)
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1
Azienda Ospedaliero-Universitaria Umberto I, Clinica di Oncologia Medica
Ancona, Italy, 60020
2
Azienda Ospedaliera Ospedali Riuniti di Bergamo, UO di Oncologia Medica
Bergamo, Italy, 24128
3
Azienda Istituti Ospitalieri di Cremona, UO di Oncologia Medica
Cremona, Italy, 26100
4
Azienda Sanitaria Ospedaliera S. Croce e Carle, UO di Oncologia Medica
Cuneo, Italy, 12100