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Gemcitabine Versus Cisplatin and Gemcitabine in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer in Poor Physical Condition (Performance Status 2)

Phase 3
18 Years
70 Years
Open (Enrolling)
Non-Small Cell Lung Cancer

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Trial Information

Gemcitabine Versus Cisplatin and Gemcitabine in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer in Poor Physical Condition (Performance Status 2)

Performance status is one of the most important prognostic factors for patients with
advanced non-small cell lung cancer (NSCLC), regardless of treatment received. Chemotherapy
is recommended for advanced NSCLC patients in good clinical condition, but it is not clear
how much benefit is gained from giving chemotherapy to patients in poor general condition
(performance status 2). This category of patients represents about 20% of all patients at
initial diagnosis of NSCLC, and remains a treatment challenge for the clinician. There have
been very few studies that have evaluated the impact of chemotherapy for this group of
patients, and there is no established standard therapy. Studies evaluating single agent and
combination two-agent chemotherapy regimens' impact on survival and improving symptoms are

Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of advanced non small cell lung
cancer, not amenable to surgical or curative radiation therapy (stage IIIB or IV);

- No prior or concomitant chemotherapy (adjuvant/neoadjuvant chemotherapy permitted if
concluded at least one year prior to enrollment);

- ECOG performance status 2;

- Age: > or = 18 and < 70 years;

- Life expectancy at least 4 weeks;

- Normal bone marrow, hepatic and renal function defined as: neutrophils > or =
2000/mm3, PLT > or = 100,000/mm3, Hb > or = 10.0 g/dl, Bilirubin > or = 1.5 times the
upper normal limit (UNL), AST and ALT < or = 3 times the UNL (5 times in the presence
of liver metastases), creatinine within normal limits;

- Signed informed consent.

Exclusion Criteria:

- Active systemic infections;

- Severe concomitant illness (congestive heart failure, angina pectoris, myocardial
infarction within previous 6 months, cardiac arrhythmias under treatment, severe
arterial hypertension, severe or uncontrolled diabetes mellitus);

- Inadequate hepatic or renal function;

- Radiation therapy ongoing or concluded within two weeks prior to enrollment;

- Symptomatic cerebral metastases;

- Previous chemotherapy for advanced disease;

- Any condition that would, in the investigator's opinion, limit the patients ability
to provide informed consent or to comply with study procedures;

- Pregnant or nursing females;

- Any malignancy within the past 5 years (except for adequately treated carcinoma in
situ of the cervix or non melanoma skin cancer)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Cesare Gridelli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:



Italy: Ethics Committee

Study ID:




Start Date:

November 2007

Completion Date:

September 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • stage IIIB
  • Stage IV
  • chemotherapy
  • monotherapy
  • combination chemotherapy
  • poor performance status
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms