Know Cancer

or
forgot password

An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer


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

Thank you

Trial Information

An Open-Label, Multicentre, Randomised, Phase III Study Comparing Oral Topotecan to Intravenous Docetaxel in Patients With Pretreated Advanced Non Small Cell Lung Cancer


Inclusion Criteria:



- Written informed consent

- Patients with advanced non-small cell lung cancer (NSCLC).

- Patients who have received one previous chemotherapy for NSCLC.

- Full recovery from previous chemotherapy.

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

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

- At least 24 hours since prior radiotherapy providing that marked bone marrow
suppression is NOT expected. Patients who have received radiotherapy must have
recovered from any reversible side effects (e.g. nausea and vomiting).

- Laboratory criteria: Patients must have adequate bone marrow reserve and adequate
kidney and liver function.

Exclusion Criteria:

- Symptoms of brain metastasis (cancer spreading to the brain), requiring treatment
with steroids.

- Active infection.

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

- Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational
therapy for the treatment of NSCLC.

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

- Women who are pregnant or lactating.

- Patients of child-bearing potential refusing to practice adequate birth control
methods.

- Patients with conditions which might alter absorption of an oral drug.

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:

One-year survival rate

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

104864-A/387

NCT ID:

NCT00049998

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • Nonsmall Cell Lung cancer
  • advanced
  • Second-line
  • topotecan
  • Hycamtin
  • oral
  • docetaxel
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location