Topotecan Plus Cisplatin Versus Etoposide Plus Cisplatin In 1st Line Extensive Disease Small Cell Lung Cancer

Browse trials for

• Lung Neoplasms 7,243
• Small Cell Lung Carcinoma 1,203

Keywords

• First-line Cisplatin
• Small Cell Lung Cancer
• topotecan
• etoposide
• Extensive Disease

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 700 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study arms

• Active comparator
  Arm A

  Cisplatin 75 mg/m2 i.v., day 1, Etoposide 100 mg/m2 i.v., days 1-3

  Drug: Intravenous etoposide/cisplatin

• Experimental
  Arm B

  Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5

  Drug: Intravenous topotecan/cisplatin

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.

Primary outcomes

1. Median overall survival time of participants

   Time frame: Up to 1 year after randomization of the last patient

Secondary outcomes

1. Number of participants with one year survival rate of the participants

   Time frame: Up to 1 year after randomization of the last patient

2. Median time of disease progression

   Time frame: up to 1 year after randomization of the last patient

3. Median time to event (progressive disease or death) of participants

   Time frame: Up to 1 year after randomization of the last patient

4. Median time to response to chemotherapy

   Time frame: Up to 1 year after randomization of the last patient

5. Median response duration

   Time frame: Up to 1 year after randomization of the last patient

6. Number of participants with objective response

   Time frame: Up to 1 year after randomization of the last patient

7. Mean lung cancer symptom score (LCSS)

   Time frame: Up to 18 weeks

8. Mean eastern cooperative oncology group (ECOG) score

   Time frame: Up to 18 weeks

9. Number of participants with adverse events (AEs) and serious adverse events (SAEs)

   Time frame: Up to 1 year after randomization of the last patient

10. Mean change from Baseline in hemoglobin value

    Time frame: Baseline and up to 18 weeks

11. Mean change from Baseline in leukocytes, neutrophils and platelets count

    Time frame: Baseline and up to 18 weeks

12. Mean change from Baseline in red blood cells (RBCs)

    Time frame: Baseline and up to 18 weeks

13. Mean change from Baseline in Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase and Lactate dehydrogenase (LDH)

    Time frame: Baseline and up to 18 weeks

14. Mean change from Baseline in Blood urea nitrogen (BUN), Potassium, Sodium and urea

    Time frame: Baseline and up to 18 weeks

15. Mean change from Baseline in Creatinine and Total bilirubin

    Time frame: Baseline and up to 18 weeks

16. Mean change from Baseline in Creatinine clearance

17. Mean change from Baseline in total protein

    Time frame: Baseline and up to 18 weeks

18. Number of participants with abnormal urinalysis results

19. Mean change from Baseline in weight

    Time frame: Baseline and up to 18 weeks

20. Mean change from Baseline in Body surface area

    Time frame: Baseline and up to 18 weeks