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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
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   (Adult, Senior)
Genders 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
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

Locations
Italy
Azienda Ospedaliero-Universitaria Umberto I, Clinica di Oncologia Medica
Ancona, Italy, 60020
Azienda Ospedaliera Ospedali Riuniti di Bergamo, UO di Oncologia Medica
Bergamo, Italy, 24128
Azienda Istituti Ospitalieri di Cremona, UO di Oncologia Medica
Cremona, Italy, 26100
Azienda Sanitaria Ospedaliera S. Croce e Carle, UO di Oncologia Medica
Cuneo, Italy, 12100
Ospedale S. Croce, U.O. di Oncologia Medica
Fano, PU, Italy, 61032
Azienda Ospedaliera Careggi, UO di Oncologia Medica
Firenze, Italy, 50139
EO Ospedali Galliera, SC Oncologia Medica
Genova, Italy, 16128
Ospedale Versilia, UO di Oncologia Medica
Lido di Camaiore, LU, Italy, 55043
USL 6, Presidio Ospedaliero di Livorno, U.O. di Oncologia MedicaAzienda
Livorno, Italy, 57122
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-IRST, Oncologia Medica
Meldola, FC, Italy, 47014
Istituto Nazionale Tumori, SC di Oncologia 2
Milano, Italy, 20133
Azienda Ospedaliero-Universitaria di Modena-Policlinico, U.O. di Oncologia Medica ed Ematologia
Modena, Italy, 41100
AO S. Gerardo, Nuovo Ospedale S. Gerardo-settore A, Oncologia Medica
Monza, MI, Italy, 20052
Azienda Ospedaliero-Universitaria di Parma, UOC di Oncologia Medica
Parma, Italy, 43100
Ospedale Silvestrini, S.C. di Oncologia Medica
Perugia, Italy, 06156
Arcispedale Santa Maria Nuova, UO di Oncologia Medica
Reggio Emilia, Italy, 42100
Azienda Ospedaliera S. Camillo-Forlanini, U.O. di Oncologia Medica
Roma, Italy, 00151
Ospedale SS. Annunziata, UO di Oncologia Medica
Sassari, Italy, 07100
Azienda Sanitaria Ospedaliera Molinette, U.O. di Oncologia Medica
Torino, Italy, 10126
P.O. Treviglio-Caravaggio, U.O. di Oncologia Medica
Treviglio, BG, Italy, 24047
Policlinico "G. B. Rossi"-Borgo Roma, U.O. di Oncologia Medica Clinicizzata
Verona, Italy, 37126
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 
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:
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

ClinicalTrials.gov processed this record on January 17, 2017