A phase III randomized study with Paclitaxel (Taxol) and Gemcitabine or Vinorelbine in patients with stage IIIBw - IV non-operable non-small cell lung cancer (NSCLC), performance status (PS) 0,1.

Phase 3

Completed

• Conditions: on-Small Cell Lung Cancer; Non-Small Cell Lung Cancer; Cancer - Lung - Non small cell

• Registration Number: ACTRN12609000946213
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 441

Inclusion Criteria

Histologically proven inoperable or recurrent or metastatic NSCLC stage IIIBw and IV. Biopsy, fine needle aspiration or sputum cytology will be used to obtain the samples.
Performance status 0, 1 of the Eastern Cooperative Oncology Group (ECOG) scale .
Measurable disease outside prior radiotherapy ports required , unless subsequent progression is documented .
Stable brain metastases .
Prior surgery or radiotherapy is allowed .
Age > 18 years .
Life expectancy at least 12 weeks.
White Blood Cells (WBC) > 4.000/ml or platelets > 100.000/ml, Bilirubin < 1.2 mg/dl, gamma-glutamyltranspeptidase, alkaline phosphatase (ALP) normal, serum creatinine < 1.4 mg/dl and creatinine clearance > 60 ml/min.
Informed consent has to be signed.

Exclusion Criteria

Past or current history of neoplasm, except for Basal cell carcinoma of the skin or carcinoma in situ of the cervix.
Previous treatment with chemotherapy for recurrent or metastatic disease.
History of atrial or ventricular arrhythmias, congestive heart failure even if medically controlled. Documented myocardial infarction.
Pre – existing motor or sensory neurotoxicity grade >2 according to World Health Organisation (WHO) scale (intolerable paresthesias and/or marked motor loss , or worse).
Active infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment .

Study & Design

• Study Type: Interventional
• Study Design: Not specified