Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Gruppo Oncologico Italiano di Ricerca Clinica.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Gruppo Oncologico Italiano di Ricerca Clinica
ClinicalTrials.gov Identifier:
NCT00786331
First Posted: November 6, 2008
Last Update Posted: August 3, 2009
Information provided by:
Gruppo Oncologico Italiano di Ricerca Clinica
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Advanced Non-Small Cell Lung Cancer | Drug: Pemetrexed Drug: Pemetrexed plus carboplatin | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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). |
Resource links provided by NLM:
Further study details as provided by Gruppo Oncologico Italiano di Ricerca Clinica:
Primary Outcome Measures:
- 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:
- To assess differences in terms of response rate between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 3 months ]
- To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 36 months ]
- To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 3 months ]
- To assess differences in terms of survival between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 36 months ]
| Estimated Enrollment: | 230 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786331
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Submitted: | July 1, 2008 |
| 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 |