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

This study has been terminated.
(low enrollment rate)
Sponsor:
Information provided by (Responsible Party):
Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00754364
First received: September 17, 2008
Last updated: January 28, 2014
Last verified: January 2014
  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: Pemetrexed/Carboplatin
Drug: Gemcitabine
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:


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: December 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  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
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: NCT00754364

Locations
Italy
Istituto Clinco Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Armando Santoro, MD
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

No publications provided

Responsible Party: Armando Santoro, MD, 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: January 28, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Gemcitabine
Pemetrexed
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014