Brain metastases from primary non-small cell lung cancer (NSCLC).
Conditions
Interventions
Product Name: topotecan
Product Code: SK&F-104864
Pharmaceutical Form: Capsule*
INN or Proposed INN: Topotecan hydrochloride
Current Sponsor code: SK&F-104864 (or SKF-S-104864-A)
Concentration unit: m
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of treatment with either oral topotecan plus WBRT or WBRT alone in patients with brain metastases due to NSCLC. ;Secondary Objective: The secondary objective of this study is to assess the safety and tolerability of treatment with either oral topotecan plus WBRT or WBRT alone. The pharmacogenetic and proteomic research objectives are as follows: • Investigate the relationship between genetic variations in select candidate genes in the host DNA and response (safety, efficacy, and tolerability) following treatment with topotecan. • Evaluate the baseline protein profile in a plasma sample taken at baseline and correlate with response to topotecan therapy.;Primary end point(s): The primary endpoint is overall survival. The secondary endpoints are: 6-month survival rate, response rate (CNS-radiologic), time to response (CNS-radiologic), time to progression (CNS-radiologic), time to progression (all sites-radiologic) and assessment of neurological signs and symptoms. | — |
Countries
Hungary
Outcome results
None listed