Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC

Advanced Non-Small Cell Lung Cancer Clinical Trial

Official title:

Randomized Phase II Study of Pemetrexed Versus Pemetrexed and Carboplatin as Second Line Chemotherapy in Advanced Non-small-cell Lung Cancer (NSCLC).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00786331
• Other study ID #: GOIRC 02/2006
• Secondary ID: EudraCT number 2
• Status: Recruiting
• Phase: Phase 2
• First received: July 1, 2008
• Last updated: July 31, 2009
• Start date: July 2007
• Est. completion date: December 2009

Study information

• Verified date: July 2009
• Source: Gruppo Oncologico Italiano di Ricerca Clinica
• Contact: Luca Boni, MD
• Phone: +39 0557947553
• Email: bonil[@]aou-careggi.toscana.it
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Non-Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Pemetrexed
Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 of a 21 days cycle
• Pemetrexed plus carboplatin
Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 and Carboplatin AUC 5 i.v. over approximately 30 minutes on day 1 (beginning approximately 30 minutes after the end of the pemetrexed infusion) of a 21 days cycle

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria Umberto I, Clinica di Oncologia Medica	Ancona
Italy	Azienda Ospedaliera Ospedali Riuniti di Bergamo, UO di Oncologia Medica	Bergamo
Italy	Azienda Istituti Ospitalieri di Cremona, UO di Oncologia Medica	Cremona
Italy	Azienda Sanitaria Ospedaliera S. Croce e Carle, UO di Oncologia Medica	Cuneo
Italy	Ospedale S. Croce, U.O. di Oncologia Medica	Fano, PU
Italy	Azienda Ospedaliera Careggi, UO di Oncologia Medica	Firenze
Italy	EO Ospedali Galliera, SC Oncologia Medica	Genova
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	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Oncologia Medica	Meldola, FC
Italy	Istituto Nazionale Tumori, SC di Oncologia 2	Milano
Italy	Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia	Modena
Italy	AO S. Gerardo, Nuovo Ospedale S. Gerardo-settore A, Oncologia Medica	Monza, MI
Italy	Azienda Ospedaliero-Universitaria di Parma, UOC di Oncologia Medica	Parma
Italy	Ospedale Silvestrini, S.C. di Oncologia Medica	Perugia
Italy	Arcispedale Santa Maria Nuova, UO di Oncologia Medica	Reggio Emilia
Italy	Azienda Ospedaliera S. Camillo-Forlanini, U.O. di Oncologia Medica	Roma
Italy	Ospedale SS. Annunziata, UO di Oncologia Medica	Sassari
Italy	Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica	Torino
Italy	P.O. Treviglio-Caravaggio, U.O. di Oncologia Medica	Treviglio, BG
Italy	Policlinico "G. B. Rossi"-Borgo Roma, U.O. di Oncologia Medica Clinicizzata	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Gruppo Oncologico Italiano di Ricerca Clinica

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To assess differences in terms of response rate between the combination pemetrexed-carboplatin and pemetrexed alone.		3 months	No
Secondary	To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone.		36 months	No
Secondary	To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone.		3 months	Yes
Secondary	To assess differences in terms of survival between the combination pemetrexed-carboplatin and pemetrexed alone.		36 months	No