Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer

Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as First Line Therapy in Chemotherapy Naive Patients With Extensive Disease (ED) Stage Small Cell Lung Cancer (SCLC)

The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell lung cancer

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Inclusion Criteria:

• Histologically or cytologically proven Small-cell lung cancer (SCLC)

• Stage of extensive disease defined by the presence of distant metastases

• At least 1 unidimensionally measureable lesion

• WHO performance status 0 to 1

• No previous SCLC-related chemotherapy

• No previous SCLC-related surgery

• No previous radiotherapy (excepting for brain metastasis)

• Adequate function of major organs and systems

  • Nervous system

    • No Grade 2 or greater peripheral neuropathy

  • Cardiovascular:

    • No symptomatic congestive heart failure
    • No unstable angina pectoris
    • No arrythmia needing continuous treatment
    • No other uncontrolled concurrent illness

Exclusion Criteria:

• Superior vena cava syndrome or obstruction of any vital structure
• Untreated malignant hypercalcemia
• Pleural effusion as the only manifestation of disease
• Extensive disease amenable to radiation therapy
• Symptomatic brain metastases requiring whole brain irradiation
• Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix