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

Armando Santoro, MD

Status and phase: Terminated; Phase 2

Conditions: NSCLC

Treatments: Drug: Pemetrexed/Carboplatin; Drug: Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT00754364

ONC-2007-003

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Pemetrexed/Carboplatin

Experimental group

Description:

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

Treatment:

Drug: Pemetrexed/Carboplatin

Gemcitabine

Active Comparator group

Description:

Gemcitabine 1250 mg/mq

Treatment:

Drug: Gemcitabine