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Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00043927
Recruitment Status : Completed
First Posted : August 16, 2002
Last Update Posted : August 21, 2013
Sponsor:
Information provided by:
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE August 14, 2002
First Posted Date  ICMJE August 16, 2002
Last Update Posted Date August 21, 2013
Study Start Date  ICMJE April 2001
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2006)
Overall Survival
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00043927 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2006)
response rates, response duration, time to progression, tolerability and patient-perceived disease status and well being for patients
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults
Official Title  ICMJE An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer.
Brief Summary This study will gather and compare data about the effectiveness and safety of two different treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received previous chemotherapy. One treatment will use an investigational drug in combination with an FDA approved chemotherapy. The other treatment will use a combination of two FDA approved chemotherapy drugs.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: topotecan/cisplatin
  • Drug: etoposide/cisplatin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: March 6, 2006)
760
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Written informed consent (patient's written understanding of and agreement to participate in this study).
  • Patients with confirmed extensive small cell lung cancer (SCLC).
  • No prior chemotherapy within 5 years of the diagnosis of SCLC.
  • Presence of either measurable or non-measurable SCLC by X-ray or physical examination.
  • At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient).
  • At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting.
  • Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.

Exclusion Criteria:

  • Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids.
  • Any active infection.
  • Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk.
  • Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC.
  • Use of an investigational drug within 30 days before the first dose of study medication.
  • Women who are pregnant or lactating.
  • Patients of child-bearing potential who refuse to practice an adequate form of birth control.
  • Patients with clinical evidence of any stomach or intestinal (GI) condition.
  • Patients requiring treatment with the drug cyclosporin A.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Costa Rica,   Czech Republic,   Estonia,   Finland,   France,   Germany,   Honduras,   Hungary,   Italy,   Jamaica,   Korea, Republic of,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Norway,   Panama,   Poland,   Puerto Rico,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00043927
Other Study ID Numbers  ICMJE 104864-A/389
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trial, MD GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP