Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Gruppo Oncologico Italiano di Ricerca Clinica.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gruppo Oncologico Italiano di Ricerca Clinica
ClinicalTrials.gov Identifier:
NCT00786331
First received: July 1, 2008
Last updated: July 31, 2009
Last verified: July 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess differences in terms of response rate between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • To assess differences in terms of duration of response between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • To assess differences in terms of toxicity between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • To assess differences in terms of survival between the combination pemetrexed-carboplatin and pemetrexed alone. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Gruppo Oncologico Italiano di Ricerca Clinica

Additional 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
Study First Received: July 1, 2008
Last Updated: July 31, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by Gruppo Oncologico Italiano di Ricerca Clinica:
second line treatment
pemetrexed
carboplatin

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 24, 2014