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Mono Versus Polichemotherapy in Non Small Cell Lung Cancer (NSCLC) Elderly Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00754364
Recruitment Status : Terminated (low enrollment rate)
First Posted : September 18, 2008
Last Update Posted : January 29, 2014
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas

Brief Summary:

Between 10% and 25% of newly diagnosed stage IIIB/stage IV patients currently receive single agent chemotherapy regimens. A significant proportion of these patients will be elderly (70 years of age) and many oncologists would consider intravenous vinorelbine or gemcitabine to be the standard of care in this patient population. It has been demonstrated that single agent vinorelbine offers therapeutic advantages to selected NSCLC patients over best supportive care alone.

Carboplatin plus Alimta have an acceptable toxicity profile and few clinical problems so it could be acceptable its use in elderly patients.

A randomised study is being performed therefore to assess whether progression free survival, the primary efficacy endpoint for this study, achieved with Carboplatin plus Alimta is superior than achieved with gemcitabine, one of the current standards of care in elderly patients with advanced NSCLC.

Condition or disease Intervention/treatment Phase
NSCLC Drug: Pemetrexed/Carboplatin Drug: Gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Study of Progression Free Survival Comparing Gemcitabine (1000 mg/m2 Infusion) Versus Carboplatin (AUC5 Infusion) Plus Alimta (500 mg/m2 Infusion) as First-line Chemotherapy in Elderly Patients With Locally Advanced (Stage IIIb) or Metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC)
Study Start Date : October 2008
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pemetrexed/Carboplatin
Pemetrexed (500 mg/m2 infusion) plus Carboplatin (AUC5 infusion)
Drug: Pemetrexed/Carboplatin

Patients will receive Pemetrexed intravenous infusion (i.v.) via infusion pump or gravity drip, at a dose of 500 mg/m2 (over a target of 10 minutes). Pemetrexed should be administered every 21 days on the same day.

Patients will receive carboplatin intravenous continuous infusion (i.v.) over 30 minutes via infusion pump or gravity drip, at a dose of AUC5. Carboplatin should be administered every 21 days on the same day.

Active Comparator: Gemcitabine
Gemcitabine 1250 mg/mq
Drug: Gemcitabine
Patients will receive gemcitabine 1250 mg/m2 as a 30 minutes intravenous infusion on days 1 and 8 and of a 21-day cycle.Patients may continue to receive gemcitabine for up to a maximum of 6 cycles.

Primary Outcome Measures :
  1. Evaluate Progression Free Survival of Carboplatin plus Alimta vs gemcitabine in chemonaive, elderly stage IIIB-IV NSCLC patients. [ Time Frame: Efficacy after the inclusion of the last patient ]

Secondary Outcome Measures :
  1. Overall Survival Quality of life [ Time Frame: After the follow up period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • NSCLC, locally advanced (stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
  • Female or male patients aged 70 years and over
  • Measurable disease according to RECIST criteria, with at least one measurable lesion
  • No prior chemotherapy, biological or immunological therapy
  • Adeguate hepatic, renal and bone marrow function
  • ECOG Performance Status ≤ 2
  • Life expectancy of at least 12 weeks

Exclusion Criteria:

  • Newly diagnosed CNS metastases that have not been treated with surgery or radiation
  • Less than 4 weeks since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
  • Any other experimental or anti-cancer therapy within 30 days before study drug administration
  • Concurrent treatment with any other experimental or anti-cancer therapy

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 identifier (NCT number): NCT00754364

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Istituto Clinco Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Armando Santoro, MD
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Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
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Responsible Party: Armando Santoro, MD, MD, Istituto Clinico Humanitas Identifier: NCT00754364    
Other Study ID Numbers: ONC-2007-003
First Posted: September 18, 2008    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors