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

September 17, 2008
September 18, 2008
January 29, 2014
October 2008
May 2014   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00754364 on Archive Site
Overall Survival Quality of life [ Time Frame: After the follow up period ]
Same as current
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Mono Versus Polichemotherapy in Non Small Cell Lung Cancer (NSCLC) Elderly Patients
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)

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.

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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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.

  • 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.
  • Experimental: Pemetrexed/Carboplatin
    Pemetrexed (500 mg/m2 infusion) plus Carboplatin (AUC5 infusion)
    Intervention: Drug: Pemetrexed/Carboplatin
  • Active Comparator: Gemcitabine
    Gemcitabine 1250 mg/mq
    Intervention: Drug: Gemcitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2015
May 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
70 Years and older   (Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Armando Santoro, MD, Istituto Clinico Humanitas
Armando Santoro, MD
Not Provided
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
Istituto Clinico Humanitas
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP