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

Bayer

Status and phase

Completed

Phase 2

Phase 1

Conditions

Carcinoma, Small Cell

Treatments

Drug: Cisplatin

Drug: Sagopilone (BAY86-5302, ZK 219477)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00359359

310101 (Other Identifier)

91495

2006-000067-29 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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