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

NCT ID: NCT00754364

Last Updated: 2022-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2015-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pemetrexed/Carboplatin

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

Group Type: EXPERIMENTAL

Pemetrexed/Carboplatin

Intervention Type: 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.

Gemcitabine

Gemcitabine 1250 mg/mq

Group Type: ACTIVE_COMPARATOR

Gemcitabine

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Armando Santoro, MD

OTHER

Sponsor Role: lead

Responsible Party

Armando Santoro, MD

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Armando Santoro, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

Istituto Clinco Humanitas

Rozzano, Milan, Italy

Countries

Italy

Other Identifiers

ONC-2007-003

Identifier Type: -

Identifier Source: org_study_id