Status:
TERMINATED
Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer
Lead Sponsor:
Bayer
Conditions:
Small Cell Lung Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00299390
Start Date
April 1 2006
End Date
April 1 2007
Last Update
December 31 2015
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