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An Open-Label, Multicenter, Randomized, Phase III Study Comparing Combination IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Advanced (IIIB/IV) Non-Small Cell Lung Cancer (NSCLC)

Phase 2
18 Years
Not Enrolling
Non-Small-Cell Lung Cancer, Lung Cancer, Non-Small Cell

Thank you

Trial Information

An Open-Label, Multicenter, Randomized, Phase III Study Comparing Combination IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Advanced (IIIB/IV) Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria

Inclusion criteria:

- Written informed consent

- At least 18 years old

- Confirmed advanced non-small cell lung carcinoma (NSCLC)

- Received one prior chemotherapy for metastatic NSCLC excluding TAXOTERE or HYCAMTIN.
In addition, subjects are allowed to have previously received a non-cytotoxic
therapy, such as an endothelial growth factor receptor (EGFR) or angiogenesis

- Presence of either measurable or non-measurable disease by radiologic study or
physical examination.

- Full recovery and at least 21 days from prior treatment for NSCLC; 42 days from
treatment with mitomycin or nitrosureas and 30 days from prior non-cytotoxic therapy.

- At least 3 weeks since last major surgery (a lesser period is acceptable if deemed in
the best interest of the patient).

- At least 7 days since prior radiotherapy.

- A probable life expectance of at least 3 months.

- Adequate bone marrow reserve, CBC/Platelet, kidney and liver function.

Exclusion criteria:

- Concomitant malignancies or other malignancies within the last five years.

- Symptoms of brain metastases requiring treatment with steroids.

- Active infection.

- Severe medical problems other than the diagnosis of NSCLC that would limit the
ability of the subject to follow study guidelines or expose the subject to extreme

- Ongoing or planned chemotherapy (other than treatment during this study),
immunotherapy, radiotherapy, or investigational therapy for the treatment of NSCLC.

- Use of investigational drug within 30 days or 5 half-lives prior to the first dose of
study medication.

- Women who are pregnant or lactating.

- Subjects of child-bearing potential refusing to practice adequate contraception.

- Prior treatment with or history of allergic reaction to either HYCAMTIN or TAXOTERE.

- Subjects who cannot receive steroid premedication.

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival - defined as the time from randomization to death. Occurs when all randomized subjects had at least one year of follow-up past their date of randomization to treatment.

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:



Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Study ID:




Start Date:

August 2003

Completion Date:

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • Lung Cancer, Non-Small Cell
  • Stage IIIB/IV
  • topotecan
  • docetaxel
  • non-small cell lung cancer
  • Advanced
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



GSK Investigational Site Phoenix, Arizona  85013 - 4496
GSK Investigational Site Little Rock, Arkansas  72205
GSK Investigational Site Bakersfield, California  93309
GSK Investigational Site Gainesville, Florida  32610
GSK Investigational Site Indianapolis, Indiana  46260
GSK Investigational Site Lexington, Kentucky  40536-0098
GSK Investigational Site New Orleans, Louisiana  70112
GSK Investigational Site Springfield, Massachusetts  01107
GSK Investigational Site Duluth, Minnesota  55805
GSK Investigational Site St. Louis, Missouri  63141
GSK Investigational Site Raleigh, North Carolina  27609
GSK Investigational Site Akron, Ohio  44304
GSK Investigational Site Fort Worth, Texas  76104
GSK Investigational Site Green Bay, Wisconsin  54301
GSK Investigational Site Savannah, Georgia  31405
GSK Investigational Site Park Ridge, Illinois  60068
GSK Investigational Site Baltimore, Maryland  21201
GSK Investigational Site Royal Oak, Michigan  48073
GSK Investigational Site Pittsburgh, Pennsylvania  15213
GSK Investigational Site Columbia, South Carolina  29210
GSK Investigational Site Germantown, Tennessee  38138
GSK Investigational Site Salem, Virginia  24153
GSK Investigational Site New York, New York  10021
GSK Investigational Site Birmingham, Alabama  35209
GSK Investigational Site Aurora, Colorado  80012
GSK Investigational Site Washington, District of Columbia  20307-5001
GSK Investigational Site Henderson, Nevada  89014
GSK Investigational Site Edison, New Jersey  08837
GSK Investigational Site Seattle, Washington  98133
GSK Investigational Site Cheyenne, Wyoming  82001