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

NCT00754364 | Terminated Phase 2

• 1 other identifier: ONC-2007-003
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Evaluate Progression Free Survival of Carboplatin plus Alimta vs gemcitabine in chemonaive, elderly stage IIIB-IV NSCLC patients.

  Efficacy after the inclusion of the last patient

Secondary Outcomes (1)

• Overall Survival Quality of life

  After the follow up period

Study Arms (2)

Pemetrexed/Carboplatin

EXPERIMENTAL

Pemetrexed (500 mg/m2 infusion) plus Carboplatin (AUC5 infusion)

Drug: Pemetrexed/Carboplatin

Gemcitabine

ACTIVE COMPARATOR

Gemcitabine 1250 mg/mq

Drug: Gemcitabine

Interventions

Pemetrexed/Carboplatin DRUG

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.

Pemetrexed/Carboplatin

Gemcitabine DRUG

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.

Gemcitabine

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Armando Santoro, MD: lead

Study Sites (1)

Istituto Clinco Humanitas

Rozzano, Milan, 20089, Italy

Location

MeSH Terms

Interventions

Pemetrexed; Carboplatin; Gemcitabine

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Armando Santoro, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2015
• Last Updated: September 10, 2022

Record last verified: 2022-09

Locations

IT (1)