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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

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.

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: topotecan/cisplatin Drug: etoposide/cisplatin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : April 2001
Primary Completion Date : January 2004

Resource links provided by the National Library of Medicine

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




Primary Outcome Measures :
  1. Overall Survival

Secondary Outcome Measures :
  1. response rates, response duration, time to progression, tolerability and patient-perceived disease status and well being for patients


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00043927


  Show 176 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trial, MD GlaxoSmithKline

ClinicalTrials.gov Identifier: NCT00043927     History of Changes
Other Study ID Numbers: 104864-A/389
First Posted: August 16, 2002    Key Record Dates
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by GlaxoSmithKline:
Chemotherapy-naive
Small Cell Lung Cancer
SCLC
Extensive disease
ED
topotecan
Hycamtin
oral

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
Topotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors