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Completed

NCT Number: NCT00320359

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

Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer

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Key information

Conditions

Lung Cancer, Small Cell Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Bludesch, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intravenous topotecan/cisplatin

Drug

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.

Intravenous etoposide/cisplatin

Drug

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open-Label, Multicentre, Randomised, Phase III Study Comparing Topotecan/Cisplatin and Topotecan/Etoposide Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
May 3, 2006
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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