Lung Cancer, Small Cell
Conditions
Keywords
First-line Cisplatin, Small Cell Lung Cancer, topotecan, etoposide, Extensive Disease
Brief summary
Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer
Interventions
DRUGIntravenous topotecan/cisplatin
Topotecan 1 mg/m2 should be administered intravenously over a period of 30 minutes on days 1-5. Then a 30 minute saline flush should be administered followed by the cisplatin on day 5. Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 5 after topotecan.
DRUGIntravenous etoposide/cisplatin
Cisplatin 75 mg/m2 given as an intravenous infusion at the rate of 1 mg/min on day 1. Cisplatin should be given simultaneously to post-hydration to ensure a high volume fluid. Etoposide 100 mg/m2 should be administered after cisplatin intravenously over a period not less than 30 minutes on days 1 -3.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Evaluable extensive small cell lung cancer, extensive disease. * Eastern Cooperative Oncology Group (ECOG) performance status \< 2. * Life expectancy \> 3 months. * Fit to receive any of the treatments. * No prior chemotherapy. * Written informed consent.
Exclusion criteria
* Extensive disease treatable with radiotherapy. * Past or current history of other malignant disease. * Prior chemotherapy. * Pregnancy, lactating or lack of effective contraception. * Concurrent severe medical problems other than small cell lung cancer. * Patients with central nervous system metastases receiving more than 12 mg /day dexamethasone or equivalent to control symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median overall survival time of participants | Up to 1 year after randomization of the last patient |
Secondary
| Measure | Time frame |
|---|---|
| Mean eastern cooperative oncology group (ECOG) score | Up to 18 weeks |
| Median time to event (progressive disease or death) of participants | Up to 1 year after randomization of the last patient |
| Median time to response to chemotherapy | Up to 1 year after randomization of the last patient |
| Median response duration | Up to 1 year after randomization of the last patient |
| Number of participants with objective response | Up to 1 year after randomization of the last patient |
| Number of participants with one year survival rate of the participants | Up to 1 year after randomization of the last patient |
| Median time of disease progression | up to 1 year after randomization of the last patient |
| Number of participants with adverse events (AEs) and serious adverse events (SAEs) | Up to 1 year after randomization of the last patient |
| Mean change from Baseline in hemoglobin value | Baseline and up to 18 weeks |
| Mean lung cancer symptom score (LCSS) | Up to 18 weeks |
| Mean change from Baseline in red blood cells (RBCs) | Baseline and up to 18 weeks |
| Mean change from Baseline in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase and Lactate dehydrogenase (LDH) | Baseline and up to 18 weeks |
| Mean change from Baseline in Blood urea nitrogen (BUN), Potassium, Sodium and urea | Baseline and up to 18 weeks |
| Mean change from Baseline in Creatinine and Total bilirubin | Baseline and up to 18 weeks |
| Mean change from Baseline in Creatinine clearance | — |
| Mean change from Baseline in total protein | Baseline and up to 18 weeks |
| Number of participants with abnormal urinalysis results | — |
| Mean change from Baseline in weight | Baseline and up to 18 weeks |
| Mean change from Baseline in Body surface area | Baseline and up to 18 weeks |
| Mean change from Baseline in leukocytes, neutrophils and platelets count | Baseline and up to 18 weeks |
Countries
Austria, Germany
Outcome results
None listed