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Topotecan and Cisplatin Versus Etoposide and Carboplatin in 1st Line Treatment of Patients With Small Cell Lung Cancer and Extensive Disease (SCLC-ED)

This study is currently recruiting participants.
Verified June 2011 by Danish Oncological Lung Cancer Group
Sponsor:
Information provided by:
Danish Oncological Lung Cancer Group
ClinicalTrials.gov Identifier:
NCT00812266
First received: December 19, 2008
Last updated: June 23, 2011
Last verified: June 2011
History of Changes
  Purpose

Randomised trial comparing standard chemotherapy with carboplatin and etoposide with a combination of topotecan and cisplatin in patients with inoperable lung cancer of small cell type.


Condition Intervention Phase
Extensive Disease
First-Line
Small Cell Lung Cancer
 Drug: topotecan + cisplatin
Drug: Etoposide + carboplatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial of Topotecan and Cisplatin Versus Etoposide and Carboplatin in the Treatment of Patients With Previously Untreated Small Cell Lung Cancer and Extensive Disease

Resource links provided by NLM:

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

Further study details as provided by Danish Oncological Lung Cancer Group:

Primary Outcome Measures:
  • 2 years survival [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rates [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 380
Study Start Date: January 2006
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Topotecan + cisplatin
 Drug: topotecan + cisplatin
topotecan IV 2 mg/sqm d1-3 + cisplatin IV 50 mg/sqm d3 q3W
Active Comparator: B
Etoposide + carboplatin
 Drug: Etoposide + carboplatin
Etoposide 120 mg/sqm IV d 1-3 + carboplatin AUC 5 d1 q3W

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed SCLC
  • Extensive stage
  • No prior chemotherapy
  • WHO PS 0-3
  • Adequate organ function (liver, kidney)
  • Adequate hematology (bone marrow)
  • Informed consent

Exclusion Criteria:

  • PS 4
  • Inadequate organ function
  • Uncontrolled infection
  • Concomitant major medical contraindications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00812266

Contacts
Contact: Seppo W Langer, MD PhD +45 35458680 seppo@rh.dk
Contact: Morten Mau-Sorensen, MD PhD +4535460879

Locations
Denmark
Dept. Oncology, Rigshospitalet Recruiting
Copenhagen, Denmark
Contact: Seppo W Langer, MD PhD     +45 35458680     seppo@rh.dk    
Sponsors and Collaborators
Danish Oncological Lung Cancer Group
Investigators
Principal Investigator: Seppo W Langer, MD PhD Dept. of Oncology, Rigshospitalet, Copenhagen
  More Information

No publications provided

Responsible Party: DOLG, Dept. of Oncology, Rigshospitalet, Copenhagen
ClinicalTrials.gov Identifier: NCT00812266     History of Changes
Other Study ID Numbers: DOLG7, DOLG7
Study First Received: December 19, 2008
Last Updated: June 23, 2011
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Danish Oncological Lung Cancer Group:
SCLC
Extensive disease
topotecan

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Cisplatin
Etoposide
 Carboplatin
Topotecan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013