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Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults
This study has been completed.
First Received: August 14, 2002   Last Updated: March 6, 2006   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00043927
  Purpose

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 Intervention Phase
Small Cell Lung Cancer
Drug: topotecan/cisplatin
Drug: etoposide/cisplatin
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Overall Survival

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

Estimated Enrollment: 760
Study Start Date: April 2001
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00043927

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United States, Alabama
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Hoover, Alabama, United States, 35216
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Sacramento, California, United States, 95816-5616
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Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trial, MD GlaxoSmithKline
  More Information

No publications provided

Study ID Numbers: 104864-A/389
Study First Received: August 14, 2002
Last Updated: March 6, 2006
ClinicalTrials.gov Identifier: NCT00043927     History of Changes
Health Authority: United States: Food and Drug Administration;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Etoposide
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Adenocarcinoma
Topotecan
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 22, 2009