Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer

Phase 2

Terminated

• Conditions: Small Cell Lung Carcinoma
• Interventions: Drug: Sagopilone (BAY86-5302, ZK 219477)

• Registration Number: NCT00299390
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to determine whether the study drug is effective and safe in the first line treatment of patients with small cell 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.

Study Timeline

• Study First Submitted: 2006-03-03
• Study First Submitted QC: 2006-03-03
• Study First Posted: 2006-03-06
• Study Start: 2006-04
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-30
• Last Update Posted: 2015-12-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Histologically or cytologically proven Small-cell lung cancer (SCLC)

• Stage of extensive disease defined by the presence of distant metastases

• At least 1 unidimensionally measureable lesion

• WHO performance status 0 to 1

• No previous SCLC-related chemotherapy

• No previous SCLC-related surgery

• No previous radiotherapy (excepting for brain metastasis)

• Adequate function of major organs and systems

  • Nervous system

    • No Grade 2 or greater peripheral neuropathy

  • Cardiovascular:

    • No symptomatic congestive heart failure
    • No unstable angina pectoris
    • No arrythmia needing continuous treatment
    • No other uncontrolled concurrent illness

Exclusion Criteria

• Superior vena cava syndrome or obstruction of any vital structure
• Untreated malignant hypercalcemia
• Pleural effusion as the only manifestation of disease
• Extensive disease amenable to radiation therapy
• Symptomatic brain metastases requiring whole brain irradiation
• Any concomitant malignancy excepting non-melanoma skin cancer or carcinoma in situ of the cervix

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sagopilone	Sagopilone (BAY86-5302, ZK 219477)	-

Primary Outcome Measures

Name	Time	Method
Response to treatment according to the modRECIST (complete response or partial response)	Every 2 cycles until tumor progression i.e. approximately every 6 weeks

Secondary Outcome Measures

Name	Time	Method
Duration of complete or partial tumor response	Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Number of participants with adverse events	Approximately 30 weeks
Time to tumor progression	Every 2 cycles until tumor progression i.e. approximately every 6 weeks