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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00320359
First received: May 1, 2006
Last updated: February 27, 2017
Last verified: February 2017
  Purpose
Evaluation of intravenous Topotecan + Cisplatin as a potential new standard of care in 1st line Small Cell Lung Cancer

Condition Intervention Phase
Lung Cancer, Small Cell Drug: Intravenous topotecan/cisplatin Drug: Intravenous etoposide/cisplatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Median overall survival time of participants [ Time Frame: Up to 1 year after randomization of the last patient ]

Secondary Outcome Measures:
  • Number of participants with one year survival rate of the participants [ Time Frame: Up to 1 year after randomization of the last patient ]
  • Median time of disease progression [ Time Frame: up to 1 year after randomization of the last patient ]
  • Median time to event (progressive disease or death) of participants [ Time Frame: Up to 1 year after randomization of the last patient ]
  • Median time to response to chemotherapy [ Time Frame: Up to 1 year after randomization of the last patient ]
  • Median response duration [ Time Frame: Up to 1 year after randomization of the last patient ]
  • Number of participants with objective response [ Time Frame: Up to 1 year after randomization of the last patient ]
  • Mean lung cancer symptom score (LCSS) [ Time Frame: Up to 18 weeks ]
  • Mean eastern cooperative oncology group (ECOG) score [ Time Frame: Up to 18 weeks ]
  • Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Up to 1 year after randomization of the last patient ]
  • Mean change from Baseline in hemoglobin value [ Time Frame: Baseline and up to 18 weeks ]
  • Mean change from Baseline in leukocytes, neutrophils and platelets count [ Time Frame: Baseline and up to 18 weeks ]
  • Mean change from Baseline in red blood cells (RBCs) [ Time Frame: Baseline and up to 18 weeks ]
  • 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 ]
  • Mean change from Baseline in Blood urea nitrogen (BUN), Potassium, Sodium and urea [ Time Frame: Baseline and up to 18 weeks ]
  • Mean change from Baseline in Creatinine and Total bilirubin [ Time Frame: Baseline and up to 18 weeks ]
  • Mean change from Baseline in Creatinine clearance
  • Mean change from Baseline in total protein [ Time Frame: Baseline and up to 18 weeks ]
  • Number of participants with abnormal urinalysis results
  • Mean change from Baseline in weight [ Time Frame: Baseline and up to 18 weeks ]
  • Mean change from Baseline in Body surface area [ Time Frame: Baseline and up to 18 weeks ]

Enrollment: 700
Study Start Date: August 2002
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Experimental: Arm B
Topotecan 1 mg/ m2, i.v., days 1-5 Cisplatin 75 mg/m2 i.v., days 5
Drug: Intravenous 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.


  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320359

  Show 79 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00320359     History of Changes
Other Study ID Numbers: 104864-A/479
Study First Received: May 1, 2006
Last Updated: February 27, 2017

Keywords provided by GlaxoSmithKline:
First-line Cisplatin
Small Cell Lung Cancer
topotecan
etoposide
Extensive Disease

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Cisplatin
Etoposide
Topotecan
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors

ClinicalTrials.gov processed this record on September 19, 2017