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A Randomized Phase II Study of Progression Free Survival Comparing Gemcitabine (1000 mg/m2 Infusion) Versus Carboplatin (AUC5 Infusion) Plus Alimta (500 mg/m2 Infusion) as First-line Chemotherapy in Elderly Patients With Locally Advanced (Stage IIIb) or Metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC)


Phase 2
70 Years
N/A
Open (Enrolling)
Both
NSCLC

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Trial Information

A Randomized Phase II Study of Progression Free Survival Comparing Gemcitabine (1000 mg/m2 Infusion) Versus Carboplatin (AUC5 Infusion) Plus Alimta (500 mg/m2 Infusion) as First-line Chemotherapy in Elderly Patients With Locally Advanced (Stage IIIb) or Metastatic (Stage IV) Non Small Cell Lung Cancer (NSCLC)


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Efficacy after the inclusion of the last patient

Safety Issue:

Yes

Principal Investigator

Armando Santoro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Clinico Humanitas

Authority:

Italy: Ministry of Health

Study ID:

ONC-2007-003

NCT ID:

NCT00754364

Start Date:

October 2008

Completion Date:

April 2015

Related Keywords:

  • NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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