Trial Condition(s):

Small Cell Lung Carcinoma

Safety and efficacy study of a new chemotherapy agent to treat small cell lung cancer

Bayer Identifier:

91375

ClinicalTrials.gov Identifier:

NCT00299390

EudraCT Number:

2005-000597-53

Terminated/Withdrawn

Trial Purpose

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

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

Trial Summary

Enrollment Goal
10
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Großhansdorf, Germany, 22927

Status
Completed
 
Locations

Investigative Site

Hamburg, Germany, 21075

Status
Completed
 
Locations

Investigative Site

Löwenstein, Germany, 74245

Status
Completed
 
Locations

Investigative Site

Halle, Germany, 06120

Status
Completed
 

Trial Design