Trial Condition(s):

Carcinoma, Small Cell

A study of a new chemotherapy agent in combination with cisplatin to treat small cell lung cancer

Bayer Identifier:

91495

ClinicalTrials.gov Identifier:

NCT00359359

EudraCT Number:

2006-000067-29

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
26
Trial Dates
black-arrow
Phase
1/2
Could I receive a placebo?
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Medizinische Einrichtungen der Universität Essen

Essen, Germany, 45147

Status
Completed
 
Locations

Klinikum rechts der Isar

München, Germany, 81675

Status
Terminated
 
Locations

Städtische Kliniken Frankfurt am Main / Hoechst

Frankfurt, Germany, 65929

Status
Terminated
 
Locations

Asklepios Klinik Harburg

Hamburg, Germany, 21075

Status
Terminated
 
Locations

Klinikum der Johannes-Gutenberg-Universität

Mainz, Germany, 55131

Status
Terminated
 
Locations

Charité Campus Benjamin Franklin

Berlin, Germany, 12200

Status
Terminated
 
Locations

Klinikum Innenstadt der Ludwigs-Maximilians-Universität

München, Germany, 80336

Status
Completed
 
Locations

Klinik Löwenstein gGmbH

Löwenstein, Germany, 74245

Status
Completed
 
Locations

Klinik Schillerhöhe

Gerlingen, Germany, 70839

Status
Terminated
 
Locations

HSK, Dr.-Horst-Schmidt-Kliniken

Wiesbaden, Germany, 65199

Status
Completed
 

Trial Design