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

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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00299390

Enrollment

Registered

2006-03-06

Start date

2006-04-30

Completion date

2007-04-30

Last updated

2015-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Carcinoma

Keywords

Sagopilone, Epothilone, SCLC, Small Cell Lung Cancer, Lung Cancer

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.

Interventions

DRUGSagopilone (BAY86-5302, ZK 219477)

Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026