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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
N/A
Not Enrolling
Both
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
inhibitor.

- 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
risk.

- 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:

Interventional

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:

GlaxoSmithKline

Authority:

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

Study ID:

104864/615

NCT ID:

NCT00065182

Start Date:

August 2003

Completion Date:

Related Keywords:

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

Name

Location

GSK Investigational SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteLittle Rock, Arkansas  72205
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteLexington, Kentucky  40536-0098
GSK Investigational SiteNew Orleans, Louisiana  70112
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteGreen Bay, Wisconsin  54301
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SitePark Ridge, Illinois  60068
GSK Investigational SiteBaltimore, Maryland  21201
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteSalem, Virginia  24153
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteBirmingham, Alabama  35209
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteWashington, District of Columbia  20307-5001
GSK Investigational SiteHenderson, Nevada  89014
GSK Investigational SiteEdison, New Jersey  08837
GSK Investigational SiteSeattle, Washington  98133
GSK Investigational SiteCheyenne, Wyoming  82001