stop_circleTerminated/Withdrawn

Small Cell Lung Carcinoma

Bayer Identifier:

91375

ClinicalTrials.gov Identifier:

NCT00299390

EudraCT Number:

2005-000597-53

EU CT Number:

Not Available
Safety and efficacy study of a new chemotherapy agent to treat small cell lung cancer

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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
April 2006 - April 2007
Phase
Phase 2
Could I Receive a placebo
No
Products
Sagopilone (BAY86-5302)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Großhansdorf, 22927, Germany
Withdrawn
Gauting, 82131, Germany
Completed
Hamburg, 21075, Germany
Completed
Löwenstein, 74245, Germany
Withdrawn
Berlin, 14109, Germany
Completed
Halle, 06120, Germany

Primary Outcome

  • Response to treatment according to the modRECIST (complete response or partial response)
    date_rangeTime Frame:
    Every 2 cycles until tumor progression i.e. approximately every 6 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Duration of complete or partial tumor response
    date_rangeTime Frame:
    Every 2 cycles until tumor progression i.e. approximately every 6 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Time to tumor progression
    date_rangeTime Frame:
    Every 2 cycles until tumor progression i.e. approximately every 6 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with adverse events
    date_rangeTime Frame:
    Approximately 30 weeks
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe.