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Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC

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ClinicalTrials.gov Identifier: NCT00786331
Recruitment Status : Unknown
Verified July 2009 by Gruppo Oncologico Italiano di Ricerca Clinica.
Recruitment status was:  Recruiting
First Posted : November 6, 2008
Last Update Posted : August 3, 2009
Sponsor:
Information provided by:
Gruppo Oncologico Italiano di Ricerca Clinica

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

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

Locations
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Sponsors and Collaborators
Gruppo Oncologico Italiano di Ricerca Clinica
Investigators
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Principal Investigator: Andrea Ardizzoni, MD Gruppo Oncologico Italiano di Ricerca Clinica
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Corrado Boni, GOIRC
ClinicalTrials.gov Identifier: NCT00786331    
Other Study ID Numbers: GOIRC 02/2006
EudraCT number 2006-004009-24
First Posted: November 6, 2008    Key Record Dates
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:
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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