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

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Epothilones; Sagopilone

Criteria

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