Randomized Phase II Study of Pemetrexed Versus Pemetrexed and Carboplatin as Second Line Chemotherapy in Advanced Non-small-cell Lung Cancer (NSCLC).
18 Years
N/A
Both
Advanced Non-Small Cell Lung Cancer
Trial Information
Randomized Phase II Study of Pemetrexed Versus Pemetrexed and Carboplatin as Second Line Chemotherapy in Advanced Non-small-cell Lung Cancer (NSCLC).
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC
Outcome Time Frame:
36 months
Safety Issue:
No
Principal Investigator
Andrea Ardizzoni, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Gruppo Oncologico Italiano di Ricerca Clinica
Authority:
Italy: Ministry of Health
Study ID:
GOIRC 02/2006
NCT ID:
NCT00786331
Start Date:
July 2007
Completion Date:
December 2009
Related Keywords:
- Advanced Non-Small Cell Lung Cancer
- second line treatment
- pemetrexed
- carboplatin
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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