Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Advanced Non-Small Cell Lung Cancer	Drug: Pemetrexed; Drug: Pemetrexed plus carboplatin	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	230 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	July 2007
Estimated Primary Completion Date :	July 2009
Estimated Study Completion Date :	December 2009

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: A; Monochemotherapy	Drug: Pemetrexed; Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 of a 21 days cycle
Experimental: B; Combination chemotherapy	Drug: 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

Outcome Measures

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Primary Outcome Measures :

1. To compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC [ Time Frame: 36 months ]

Secondary Outcome Measures :

1. To assess differences in terms of response rate between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 3 months ]
2. To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 36 months ]
3. To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 3 months ]
4. To assess differences in terms of survival between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 36 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Luca Boni, MD	+39 0557947553	bonil@aou-careggi.toscana.it

Locations

Italy
Azienda Ospedaliero-Universitaria Umberto I, Clinica di Oncologia Medica	Active, not recruiting
Ancona, Italy, 60020
Azienda Ospedaliera Ospedali Riuniti di Bergamo, UO di Oncologia Medica	Recruiting
Bergamo, Italy, 24128
Principal Investigator: Roberto Labianca, MD
Azienda Istituti Ospitalieri di Cremona, UO di Oncologia Medica	Recruiting
Cremona, Italy, 26100
Principal Investigator: Rodolfo Passalacqua, MD
Azienda Sanitaria Ospedaliera S. Croce e Carle, UO di Oncologia Medica	Recruiting
Cuneo, Italy, 12100
Principal Investigator: Marco Merlano, MD
Ospedale S. Croce, U.O. di Oncologia Medica	Recruiting
Fano, PU, Italy, 61032
Principal Investigator: Rodolfo Mattioli, MD
Azienda Ospedaliera Careggi, UO di Oncologia Medica	Recruiting
Firenze, Italy, 50139
Principal Investigator: Francesco Di Costanzo, MD
EO Ospedali Galliera, SC Oncologia Medica	Recruiting
Genova, Italy, 16128
Principal Investigator: Andrea Decensi, MD
Ospedale Versilia, UO di Oncologia Medica	Recruiting
Lido di Camaiore, LU, Italy, 55043
Principal Investigator: Domenico Amoroso, MD
USL 6, Presidio Ospedaliero di Livorno, U.O. di Oncologia MedicaAzienda	Recruiting
Livorno, Italy, 57122
Principal Investigator: Alfredo Falcone, MD
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Oncologia Medica	Recruiting
Meldola, FC, Italy, 47014
Principal Investigator: Dino Amadori, MD
Istituto Nazionale Tumori, SC di Oncologia 2	Recruiting
Milano, Italy, 20133
Principal Investigator: Emilio Baietta, MD
Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia	Recruiting
Modena, Italy, 41100
Principal Investigator: Fausto Barbieri, MD
AO S. Gerardo, Nuovo Ospedale S. Gerardo-settore A, Oncologia Medica	Not yet recruiting
Monza, MI, Italy, 20052
Principal Investigator: Paolo Bidoli, MD
Azienda Ospedaliero-Universitaria di Parma, UOC di Oncologia Medica	Recruiting
Parma, Italy, 43100
Principal Investigator: Andrea Ardizzoni, MD
Ospedale Silvestrini, S.C. di Oncologia Medica	Recruiting
Perugia, Italy, 06156
Principal Investigator: Lucio Crinò, MD
Arcispedale Santa Maria Nuova, UO di Oncologia Medica	Recruiting
Reggio Emilia, Italy, 42100
Principal Investigator: Corrado Boni, MD
Azienda Ospedaliera S. Camillo-Forlanini, U.O. di Oncologia Medica	Recruiting
Roma, Italy, 00151
Principal Investigator: Filippo De Marinis, MD
Ospedale SS. Annunziata, UO di Oncologia Medica	Recruiting
Sassari, Italy, 07100
Principal Investigator: Antonio Contu, MD
Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica	Recruiting
Torino, Italy, 10126
Principal Investigator: Libero Ciuffreda, MD
P.O. Treviglio-Caravaggio, U.O. di Oncologia Medica	Not yet recruiting
Treviglio, BG, Italy, 24047
Principal Investigator: Barni Sandro, MD
Policlinico "G. B. Rossi"-Borgo Roma, U.O. di Oncologia Medica Clinicizzata	Recruiting
Verona, Italy, 37126
Principal Investigator: Antonio Santo, MD

Sponsors and Collaborators

Gruppo Oncologico Italiano di Ricerca Clinica

Investigators

Principal Investigator:	Andrea Ardizzoni, MD	Gruppo Oncologico Italiano di Ricerca Clinica

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

van Kruijsdijk RC, Visseren FL, Boni L, Groen HJ, Dingemans AM, Aerts JG, van der Graaf Y, Ardizzoni A, Smit EF. Pemetrexed plus carboplatin versus pemetrexed in pretreated patients with advanced non-squamous non-small-cell lung cancer: treating the right patients based on individualized treatment effect prediction. Ann Oncol. 2016 Jul;27(7):1280-6. doi: 10.1093/annonc/mdw154. Epub 2016 Apr 6.

Ardizzoni A, Tiseo M, Boni L, Vincent AD, Passalacqua R, Buti S, Amoroso D, Camerini A, Labianca R, Genestreti G, Boni C, Ciuffreda L, Di Costanzo F, de Marinis F, Crinò L, Santo A, Pazzola A, Barbieri F, Zilembo N, Colantonio I, Tibaldi C, Mattioli R, Cafferata MA, Camisa R, Smit EF. Pemetrexed versus pemetrexed and carboplatin as second-line chemotherapy in advanced non-small-cell lung cancer: results of the GOIRC 02-2006 randomized phase II study and pooled analysis with the NVALT7 trial. J Clin Oncol. 2012 Dec 20;30(36):4501-7. doi: 10.1200/JCO.2012.43.6758. Epub 2012 Oct 29.

Responsible Party:	Dr. Corrado Boni, GOIRC
ClinicalTrials.gov Identifier:	NCT00786331 History of Changes
Other Study ID Numbers:	GOIRC 02/2006; EudraCT number 2006-004009-24
First Posted:	November 6, 2008
Last Update Posted:	August 3, 2009
Last Verified:	July 2009

Keywords provided by Gruppo Oncologico Italiano di Ricerca Clinica:

second line treatment; pemetrexed; carboplatin

Additional relevant MeSH terms:

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic	Bronchial Neoplasms; Carboplatin; Pemetrexed; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors