A Study of a New Chemotherapy Agent in Combination With Cisplatin to Treat Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether the study drug ZK 219477 (also known as SH Y03757A) combined with cisplatin, is effective in the treatment of small cell lung cancer in patients who did not receive prior treatment for their lung cancer

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Cisplatin; Epothilones; Sagopilone

Criteria

Inclusion Criteria:

• Small-cell lung cancer

• Stage of extensive disease

• Adequate function of major organs and systems

• Use of highly effective birth control methods in females of child-bearing potential

Exclusion Criteria:

• Prior chemotherapy for small-cell lung cancer

• Prior surgical resection or radiotherapy for SCLC within at least 3 to 4 weeks prior to inclusion and with the exception of radiation of brain metastases

• Superior vena cava syndrome or obstruction of any vital structure

• Untreated malignant hypercalcemia; Extensive disease amenable to radiation therapy; Symptomatic brain metastases requiring whole-brain irradiation

• Known allergy or hypersensitivity to platinum-containing drugs

• Pregnancy or breast-feeding

• Use of any investigational drug within 4 weeks before start of the study