Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC
- Conditions
- Advanced Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00786331
- Lead Sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 230
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Pemetrexed plus carboplatin Combination chemotherapy A Pemetrexed Monochemotherapy
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (21)
Azienda Istituti Ospitalieri di Cremona, UO di Oncologia Medica
🇮🇹Cremona, Italy
Azienda Ospedaliera Ospedali Riuniti di Bergamo, UO di Oncologia Medica
🇮🇹Bergamo, Italy
Azienda Sanitaria Ospedaliera S. Croce e Carle, UO di Oncologia Medica
🇮🇹Cuneo, Italy
Policlinico "G. B. Rossi"-Borgo Roma, U.O. di Oncologia Medica Clinicizzata
🇮🇹Verona, Italy
EO Ospedali Galliera, SC Oncologia Medica
🇮🇹Genova, Italy
Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia
🇮🇹Modena, Italy
Azienda Ospedaliera S. Camillo-Forlanini, U.O. di Oncologia Medica
🇮🇹Roma, Italy
Ospedale Versilia, UO di Oncologia Medica
🇮🇹Lido di Camaiore, LU, Italy
USL 6, Presidio Ospedaliero di Livorno, U.O. di Oncologia MedicaAzienda
🇮🇹Livorno, Italy
P.O. Treviglio-Caravaggio, U.O. di Oncologia Medica
🇮🇹Treviglio, BG, Italy
Ospedale S. Croce, U.O. di Oncologia Medica
🇮🇹Fano, PU, Italy
Arcispedale Santa Maria Nuova, UO di Oncologia Medica
🇮🇹Reggio Emilia, Italy
Azienda Ospedaliera Careggi, UO di Oncologia Medica
🇮🇹Firenze, Italy
Istituto Nazionale Tumori, SC di Oncologia 2
🇮🇹Milano, Italy
AO S. Gerardo, Nuovo Ospedale S. Gerardo-settore A, Oncologia Medica
🇮🇹Monza, MI, Italy
Ospedale Silvestrini, S.C. di Oncologia Medica
🇮🇹Perugia, Italy
Ospedale SS. Annunziata, UO di Oncologia Medica
🇮🇹Sassari, Italy
Azienda Ospedaliero-Universitaria Umberto I, Clinica di Oncologia Medica
🇮🇹Ancona, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Oncologia Medica
🇮🇹Meldola, FC, Italy
Azienda Ospedaliero-Universitaria di Parma, UOC di Oncologia Medica
🇮🇹Parma, Italy
Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica
🇮🇹Torino, Italy