Safety and Efficacy Study of a New Chemotherapy Agent to Treat Small Cell Lung Cancer

This study has been terminated.
(Since only 1 of the first 10 subjects responded to the study treatment, it was decided to stop the trial due to lack of efficacy .)
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00299390
First received: March 3, 2006
Last updated: December 30, 2015
Last verified: December 2015
  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

Condition Intervention Phase
Small Cell Lung Carcinoma
Drug: Sagopilone (BAY86-5302, ZK 219477)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of complete or partial tumor response [ Time Frame: Every 2 cycles until tumor progression i.e. approximately every 6 weeks ] [ Designated as safety issue: No ]
  • Time to tumor progression [ Time Frame: Every 2 cycles until tumor progression i.e. approximately every 6 weeks ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Approximately 30 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: April 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sagopilone Drug: Sagopilone (BAY86-5302, ZK 219477)
Sagopilone; 16 mg/m2 (maximum 32 mg) as 3 hour i.v. infusion

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00299390

Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00299390     History of Changes
Other Study ID Numbers: 91375  2005-000597-53  307972 
Study First Received: March 3, 2006
Last Updated: December 30, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Sagopilone
Epothilone
SCLC
Small Cell Lung Cancer
Lung Cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on May 25, 2016