Terminated/Withdrawn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

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

Trial Dates

April 2006 - April 2007

Phase

Phase 2

Could I Receive a placebo

Products

Sagopilone (BAY86-5302)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
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Withdrawn		Gauting, 82131, Germany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Withdrawn		Berlin, 14109, Germany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)
Time Frame:
Every 2 cycles until tumor progression i.e. approximately every 6 weeks
Safety Issue:
No

Secondary Outcome

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

Additional Information

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