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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Istituto Clinico Humanitas.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00754364
First received: September 17, 2008
Last updated: September 1, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
NSCLC
 Drug: Carboplatino, ALIMTA
Drug: Gemcitabina
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Survival Quality of life [ Time Frame: After the follow up period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 108
Study Start Date: October 2008
Estimated Study Completion Date: October 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
ALIMTA plus Carboplatino
 Drug: Carboplatino, ALIMTA
Carboplatin (AUC5)plus Alimta (500mg/m2) on day 1 of a 21-day cycle for a maximum of a 6 cycles
Active Comparator: B
Gemcitabina
 Drug: Gemcitabina
Gemcitabina 1250 mg/m2 day 1 and 8 of a 21-day cycle, for a maximum of a six cycles

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00754364

Contacts
Contact: Armando Santoro, MD +39028224 ext 4080 armando.santoro@humanitas.it
Contact: Raffaele Cavina, MD +39028224 ext 4588 raffaele.cavina@humanitas.it

Locations
Italy
Istituto Clinco Humanitas Recruiting
Rozzano, Milan, Italy, 20089
Contact: Armando Santoro, MD     +39028224 ext 4080     armando.santoro@humanitas.it    
Contact: Raffaele Cavina, MD     +39028224 ext 4588     raffaele.cavina@humanitas.it    
Sub-Investigator: Raffaele Cavina, MD            
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

No publications provided

Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00754364     History of Changes
Other Study ID Numbers: ONC-2007-003
Study First Received: September 17, 2008
Last Updated: September 1, 2010
Health Authority: Italy: Ministry of Health

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 May 23, 2013