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

• ClinicalTrials.gov Identifier: NCT00754364
• Recruitment Status: Terminated
• First Posted: September 18, 2008
• Last Update Posted: January 29, 2014
• Sponsor: Armando Santoro, MD
• Information provided by (Responsible Party): Armando Santoro, MD, Istituto Clinico Humanitas

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 70 Years and older (Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Armando Santoro, MD, MD, Istituto Clinico Humanitas
• ClinicalTrials.gov Identifier: NCT00754364
• Other Study ID Numbers: ONC-2007-003
• First Posted: September 18, 2008
• Last Update Posted: January 29, 2014
• Last Verified: January 2014

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gemcitabine; Carboplatin; Pemetrexed; Antineoplastic Agents; Antimetabolites, Antineoplastic; Antimetabolites; 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