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

Small Cell Lung Carcinoma Clinical Trial

Official title:

Phase II Study to Investigate the Efficacy and Safety of ZK 219477 as First Line Therapy in Chemotherapy Naive Patients With Extensive Disease (ED) Stage Small Cell Lung Cancer (SCLC)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00299390
• Other study ID #: 91375
• Secondary ID: 2005-000597-5330
• Status: Terminated
• Phase: Phase 2
• First received: March 3, 2006
• Last updated: December 30, 2015
• Start date: April 2006
• Est. completion date: April 2007

Study information

• Verified date: December 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Sagopilone (BAY86-5302, ZK 219477)
Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment according to the modRECIST (complete response or partial response)		Every 2 cycles until tumor progression i.e. approximately every 6 weeks	No
Secondary	Duration of complete or partial tumor response		Every 2 cycles until tumor progression i.e. approximately every 6 weeks	No
Secondary	Time to tumor progression		Every 2 cycles until tumor progression i.e. approximately every 6 weeks	No
Secondary	Number of participants with adverse events		Approximately 30 weeks	Yes

External Links

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