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

Phase 2TerminatedNCT00754364

Armando Santoro, MD108 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

108

Conditions

NSCLC

Interventions

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.

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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 Outcomes

Overall Survival Quality of life

Time frame: After the follow up period