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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.


Phase 3
18 Years
N/A
Not Enrolling
Both
Small Cell Lung Cancer

Thank you

Trial Information

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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Principal Investigator

GSK Clinical Trial, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

104864-A/389

NCT ID:

NCT00043927

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Small Cell Lung Cancer
  • Chemotherapy-naive
  • Small Cell Lung Cancer
  • SCLC
  • Extensive disease
  • ED
  • topotecan
  • Hycamtin
  • oral
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

GSK Clinical Trials Call CenterHoover, Alabama  35216
GSK Clinical Trials Call CenterChula Vista, California  91911
GSK Clinical Trials Call CenterColorado Springs, Colorado  80909
GSK Clinical Trials Call CenterNorwich, Connecticut  06360
GSK Clinical Trials Call CenterWashington, District of Columbia  20307-5001
GSK Clinical Trials Call CenterGainesville, Florida  32610
GSK Clinical Trials Call CenterAtlanta, Georgia  30328
GSK Clinical Trials Call CenterAurora, Illinois  60506
GSK Clinical Trials Call CenterEvansville, Indiana  47713
GSK Clinical Trials Call CenterNew Orleans, Louisiana  70112
GSK Clinical Trials Call CenterFrederick, Maryland  21701
GSK Clinical Trials Call CenterPittsfield, Massachusetts  01201
GSK Clinical Trials Call CenterMinneapolis, Minnesota  55404
GSK Clinical Trials Call CenterSt. Louis, Missouri  63141
GSK Clinical Trials Call CenterReno, Nevada  89502
GSK Clinical Trials Call CenterVoorhees, New Jersey  08043
GSK Clinical Trials Call CenterAlbuquerque, New Mexico  87109
GSK Clinical Trials Call CenterAlbany, New York  12208
GSK Clinical Trials Call CenterBismarck, North Dakota  58501
GSK Clinical Trials Call CenterCleveland, Ohio  44106-5065
GSK Clinical Trials Call CenterPortland, Oregon  97232-2099
GSK Clinical Trials Call CenterLemoyne, Pennsylvania  17043
GSK Clinical Trials Call CenterColumbia, South Carolina  29203
GSK Clinical Trials Call CenterMemphis, Tennessee  38119
GSK Clinical Trials Call CenterFort Worth, Texas  76104
GSK Clinical Trials Call CenterAbingdon, Virginia  24211
GSK Clinical Trials Call CenterOlympia, Washington  98506
GSK Clinical Trials Call CenterMorgantown, West Virginia  26506
GSK Clinical Trials Call CenterMadison, Wisconsin  53792
GSK Clinical Trials Call CenterLaramie, Wyoming  82070