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)
18 Years
N/A
Both
Carcinoma, Small Cell Lung
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Tumor response rate (complete or partial response according to RECIST)
Outcome Time Frame:
Every 3 weeks
Principal Investigator
Bayer Study Director
Investigator Role:
Study Director
Investigator Affiliation:
Bayer
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
91375
NCT ID:
NCT00299390
Start Date:
April 2006
Completion Date:
April 2007
Related Keywords:
- Carcinoma, Small Cell Lung
- Sagopilone
- Epothilone
- SCLC
- Small Cell Lung Cancer
- Lung Cancer
- Carcinoma
- Lung Neoplasms
- Small Cell Lung Carcinoma
- Carcinoma, Small Cell
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