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Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial


Phase 3
18 Years
75 Years
Not Enrolling
Both
Non Small Cell Lung Cancer

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Trial Information

Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial


Cisplatin-based chemotherapy represented the backbone of treatment of advanced NSCLC.
However, several trials comparing platinum versus non-platinum based chemotherapy regimens
failed to demonstrate a statistically significant difference in terms of time to tumor
progression or survival. Newer agents such as gemcitabine, docetaxel and vinorelbine have
shown significant activity in the treatment of NSCLC. Gemcitabine/vinorelbine combination as
first line treatment has demonstrated a response rate (RR) of 18-43% and a median overall
survival (OS) of 9.8-13 months. Similarly, the gemcitabine/docetaxel combination has shown a
RR 32-35% and a median OS of 9-12 months. Given their proven efficacy, the combination of
these two doublets, would be interesting.


Inclusion Criteria:



- Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB
with pleural effusion) and/or metastatic (stage IV) NSCLC

- No previous therapy for advanced/metastatic NSCLC is allowed

- Age > 18 years

- Bidimensionally measurable disease

- Performance status (WHO) 0-2

- Adequate liver (serum bilirubin < 1.5 times the upper normal limit (UNL); AST and ALT
< 2.5 times the UNL in the absence of demonstrable liver metastases, or < 5 times the
UNL in the presence of liver metastases); adequate renal function (serum creatinine <
1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x
109 /L) function

- Previous radiotherapy, either in the adjuvant setting or for the treatment of
metastatic disease is allowed provided that the measurable lesions are outside the
radiation fields

- Life expectancy of more than 3 months

- Patient able to take oral medication

- At least 4 weeks since prior radiotherapy

- Written informed consent

Exclusion Criteria:

- Active infection

- History of significant cardiac disease (unstable angina, congestive heart failure,
myocardial infarction within the previous 6 months, ventricular arrhythmias)

- Malnutrition (loss of ≥ 20% of the original body weight)

- Performance status: 3-4

- Sensor or motor neuropathy > grade I

- Second primary malignancy, except for non-melanoma skin cancer

- Psychiatric illness or social situation that would preclude study compliance

- Pregnant or lactating women

- Known, symptomatic central nervous system metastases

Type of Study:

Interventional

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:

1 year

Safety Issue:

No

Principal Investigator

Vassilis Georgoulias, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete, Dep of Medical Oncology

Authority:

Greece: National Organization of Medicines

Study ID:

CT/04.04

NCT ID:

NCT00441740

Start Date:

April 2004

Completion Date:

February 2008

Related Keywords:

  • Non Small Cell Lung Cancer
  • NSCLC
  • 1st line treatment
  • Gemcitabine
  • Vinorelbine
  • Docetaxel
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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