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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00299390
First received: March 3, 2006
Last updated: April 13, 2010
Last verified: April 2010
History of Changes
  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
Carcinoma, Small Cell Lung
 Drug: Epothilone (BAY86-5302, SH Y03757A)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Tumor response rate (complete or partial response according to RECIST) [ Time Frame: Every 3 weeks ]

Secondary Outcome Measures:
  • Duration of complete or partial tumor response [ Time Frame: Every 3 weeks ]
  • Time to tumor progression [ Time Frame: Every 3 weeks ]
  • Investigate the safety and tolerability of the above treatment [ Time Frame: Every 3 weeks ]

Enrollment: 32
Study Start Date: April 2006
Study Completion Date: April 2007
Arms Assigned Interventions
Experimental: Arm 1 Drug: Epothilone (BAY86-5302, SH Y03757A)
Epothilone; 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
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:
Click here and search for drug information provided by the FDA  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer Schering Pharma AG
ClinicalTrials.gov Identifier: NCT00299390     History of Changes
Other Study ID Numbers: 91375, EudraCT No: 2005-000597-53, 307972
Study First Received: March 3, 2006
Last Updated: April 13, 2010
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:
Carcinoma
Lung Neoplasms
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
 Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Epothilones
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013