Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC
Information source: Gruppo Oncologico Italiano di Ricerca Clinica
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Non-Small Cell Lung Cancer
Intervention: Pemetrexed (Drug); Pemetrexed plus carboplatin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Gruppo Oncologico Italiano di Ricerca Clinica Official(s) and/or principal investigator(s): Andrea Ardizzoni, MD, Principal Investigator, Affiliation: Gruppo Oncologico Italiano di Ricerca Clinica
Overall contact: Luca Boni, MD, Phone: +39 0557947553, Email: bonil@aou-careggi.toscana.it
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.
Clinical Details
Official title: Randomized Phase II Study of Pemetrexed Versus Pemetrexed and Carboplatin as Second Line Chemotherapy in Advanced Non-small-cell Lung Cancer (NSCLC).
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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: 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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Luca Boni, MD, Phone: +39 0557947553, Email: bonil@aou-careggi.toscana.it
Azienda Ospedaliero-Universitaria Umberto I, Clinica di Oncologia Medica, Ancona 60020, Italy; Active, not recruiting
Azienda Ospedaliera Ospedali Riuniti di Bergamo, UO di Oncologia Medica, Bergamo 24128, Italy; Recruiting Roberto Labianca, MD, Principal Investigator
Azienda Istituti Ospitalieri di Cremona, UO di Oncologia Medica, Cremona 26100, Italy; Recruiting Rodolfo Passalacqua, MD, Principal Investigator
Azienda Sanitaria Ospedaliera S. Croce e Carle, UO di Oncologia Medica, Cuneo 12100, Italy; Recruiting Marco Merlano, MD, Principal Investigator
Ospedale S. Croce, U.O. di Oncologia Medica, Fano, PU 61032, Italy; Recruiting Rodolfo Mattioli, MD, Principal Investigator
Azienda Ospedaliera Careggi, UO di Oncologia Medica, Firenze 50139, Italy; Recruiting Francesco Di Costanzo, MD, Principal Investigator
EO Ospedali Galliera, SC Oncologia Medica, Genova 16128, Italy; Recruiting Andrea Decensi, MD, Principal Investigator
Ospedale Versilia, UO di Oncologia Medica, Lido di Camaiore, LU 55043, Italy; Recruiting Domenico Amoroso, MD, Principal Investigator
USL 6, Presidio Ospedaliero di Livorno, U.O. di Oncologia MedicaAzienda, Livorno 57122, Italy; Recruiting Alfredo Falcone, MD, Principal Investigator
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Oncologia Medica, Meldola, FC 47014, Italy; Recruiting Dino Amadori, MD, Principal Investigator
Istituto Nazionale Tumori, SC di Oncologia 2, Milano 20133, Italy; Recruiting Emilio Baietta, MD, Principal Investigator
Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia, Modena 41100, Italy; Recruiting Fausto Barbieri, MD, Principal Investigator
AO S. Gerardo, Nuovo Ospedale S. Gerardo-settore A, Oncologia Medica, Monza, MI 20052, Italy; Not yet recruiting Paolo Bidoli, MD, Principal Investigator
Azienda Ospedaliero-Universitaria di Parma, UOC di Oncologia Medica, Parma 43100, Italy; Recruiting Andrea Ardizzoni, MD, Principal Investigator
Ospedale Silvestrini, S.C. di Oncologia Medica, Perugia 06156, Italy; Recruiting Lucio Crinò, MD, Principal Investigator
Arcispedale Santa Maria Nuova, UO di Oncologia Medica, Reggio Emilia 42100, Italy; Recruiting Corrado Boni, MD, Principal Investigator
Azienda Ospedaliera S. Camillo-Forlanini, U.O. di Oncologia Medica, Roma 00151, Italy; Recruiting Filippo De Marinis, MD, Principal Investigator
Ospedale SS. Annunziata, UO di Oncologia Medica, Sassari 07100, Italy; Recruiting Antonio Contu, MD, Principal Investigator
Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica, Torino 10126, Italy; Recruiting Libero Ciuffreda, MD, Principal Investigator
P.O. Treviglio-Caravaggio, U.O. di Oncologia Medica, Treviglio, BG 24047, Italy; Not yet recruiting Barni Sandro, MD, Principal Investigator
Policlinico "G. B. Rossi"-Borgo Roma, U.O. di Oncologia Medica Clinicizzata, Verona 37126, Italy; Recruiting Antonio Santo, MD, Principal Investigator
Additional Information
Starting date: July 2007
Last updated: July 31, 2009
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