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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00359359

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

Condition	Intervention	Phase
Carcinoma, Small Cell Lung	Drug: Sagopilone	Phase II

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of ZK 219477 in Combination With Cisplatin as First-Line Therapy in Chemotherapy-naïve Patients With Extensive-Disease (ED) Stage Small-Cell Lung Cancer (SCLC)

Further study details as provided by Bayer:

Primary Outcome Measures:

Phase 1: Safety measure to establish the MTD or RPDII dose of Sagopilone used in combination with carboplatin and bevacizumab [ Time Frame: Phase 1: Baseline up to 3 month of treatment ] [ Designated as safety issue: Yes ]
Phase 2: Efficacy measure [ Time Frame: Phase 2: every 6 weeks after start of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Phase 1: PK of Sagopilone + Cisplatin [ Time Frame: Baseline up to 6 weeks of treatment ] [ Designated as safety issue: Yes ]
Phase 2: Duration of CR or PR [ Time Frame: every 6 weeks after start of treatment ] [ Designated as safety issue: Yes ]
Phase 2: TTP [ Time Frame: every 6 weeks after start of treatment ] [ Designated as safety issue: Yes ]
Phase 2: PFS [ Time Frame: every 6 weeks after start of treatment ] [ Designated as safety issue: Yes ]
Phase 2: OS [ Time Frame: every 3 months after start of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	July 2006
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Sagopilone Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
Known allergy or hypersensitivity to platinum-containing drugs
Pregnant or breast-feeding
Use of any investigational drug within 4 weeks before start of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359359

Locations

Germany

Berlin, Germany, 12200

Hamburg, Germany, 21075
Germany, Baden-Württemberg

Löwenstein, Baden-Württemberg, Germany, 74245

Gerlingen, Baden-Württemberg, Germany, 70839
Germany, Bayern

München, Bayern, Germany, 80336

München, Bayern, Germany, 81675
Germany, Hessen

Wiesbaden, Hessen, Germany, 65199

Frankfurt, Hessen, Germany, 65929
Germany, Nordrhein-Westfalen

Essen, Nordrhein-Westfalen, Germany, 45147
Germany, Rheinland-Pfalz

Mainz, Rheinland-Pfalz, Germany, 55131

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

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Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91495, EudraCT: 2006-000067-29, 310101
Study First Received:	July 27, 2006
Last Updated:	November 28, 2008
ClinicalTrials.gov Identifier:	NCT00359359
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration

Keywords provided by Bayer:

Small Cell Lung Cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Cisplatin

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on January 16, 2009