A Randomized, Phase III, Open-Label Study of Oral Topotecan Plus Whole-Brain Radiation Therapy (WBRT) Compared with WBRT Alone in Patients with BrainMetastases from Non-Small Cell Lung Cancer. - HYT105962

• Conditions: Brain metastases from primary non-small cell lung cancer (NSCLC).

• Registration Number: EUCTR2006-002074-22-HU
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-15
• Last Update Posted: 28 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 675

Inclusion Criteria

- Signed written informed consent
- Patients must be =18 years of age
- Performance status ECOG 0, 1, or 2
- Patients with radiologically confirmed (symptomatic or asymptomatic) brain
metastases from histologically confirmed primary NSCLC
- Presence of at least one brain lesion that is bidimensionally measurable by CT or
MRI.
- Patients must have received at least one prior chemotherapy regimen for the
treatment of primary disease (NSCLC). Single-agent treatment with a tyrosine
kinase inhibitor will not be considered prior chemotherapy.
- Prior brain surgery is acceptable provided at least one brain lesion that is
bidimensionally measurable by CT or MRI is present.
- At least 4 weeks must have elapsed since any surgery.
- At least 4 weeks must have elapsed since any radiation therapy to a non-CNS site.
- Patients must have adequate bone marrow, renal, and liver capacities
- Women of child-bearing potential with adequate contraception (e.g.
oral contraceptives, diaphragm plus spermicide, or IUD) for at least 3 months prior
to study start. The same contraceptive method should be used throughout the study
and continued for at least 4 weeks after the end of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Prior radiation therapy to the CNS.
- Patients who have received prior treatment with topotecan.
- Patients who have received any investigational agent (for any tumor) within 30 days or 5 half-lives (whichever is longer) prior to randomization.
- Concomitant therapy with known inhibitors of BCRP or P-glycoprotein, such as
erlotinib or gefitinib.
- Any severe concurrent medical condition, including an active infection, that could
affect the patient's ability to comply with the protocol.
- Any known primary or secondary immunodeficiencies.
- Any condition of the GI tract which would affect GI absorption or motility (e.g.,
autonomic neuropathy, active gastric or duodenal ulcers or certain gastrointestinal
surgeries). Patients receiving medication to maintain motility or gastric emptying
are also excluded.
- Patients with uncontrolled emesis, regardless of etiology.
- Women who are pregnant or lactating.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified