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

Phase 2

Terminated

• Conditions: NSCLC
• Interventions: Drug: Gemcitabine; Drug: Pemetrexed/Carboplatin

• Registration Number: NCT00754364
• Lead Sponsor: Armando Santoro, MD

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2008-09-17
• Study First Submitted QC: 2008-09-17
• Study First Posted: 2008-09-18
• Study Start: 2008-10
• Primary Completion: 2014-05
• Study Completion: 2015-12
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-08
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 108

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine	Gemcitabine	Gemcitabine 1250 mg/mq
Pemetrexed/Carboplatin	Pemetrexed/Carboplatin	Pemetrexed (500 mg/m2 infusion) plus Carboplatin (AUC5 infusion)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Overall Survival Quality of life	After the follow up period

Trial Locations

Locations (1)

Istituto Clinco Humanitas; 🇮🇹 Rozzano, Milan, Italy