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

NCT ID: NCT00359359

Last Updated: 2014-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-08-31

Brief 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

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.

Conditions

Carcinoma, Small Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sagopilone and cisplatin

The study drug sagopilone was administered in combination with a fixed dose of cisplatin

Group Type: EXPERIMENTAL

Sagopilone (BAY86-5302, ZK 219477)

Intervention Type: DRUG

Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID

Cisplatin

Intervention Type: DRUG

75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1

Interventions

Sagopilone (BAY86-5302, ZK 219477)

Phase 1: dose escalation/deescalation, starting dose 12mg/m² Sagopilone, Phase 2: MTD or RPIID

Intervention Type: DRUG

Cisplatin

75 mg/m² as a 1 h infusion after the sagopilone infusion on Day 1

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Gerlingen, Baden-Wurttemberg, Germany

Löwenstein, Baden-Wurttemberg, Germany

München, Bavaria, Germany

München, Bavaria, Germany

Hamburg, City state of Hamburg, Germany

Frankfurt am Main, Hesse, Germany

Wiesbaden, Hesse, Germany

Essen, North Rhine-Westphalia, Germany

Mainz, Rhineland-Palatinate, Germany

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

2006-000067-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

310101

Identifier Type: OTHER

Identifier Source: secondary_id

91495

Identifier Type: -

Identifier Source: org_study_id