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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.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: May 1, 2006
Last updated: July 19, 2012
Last verified: March 2011

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:
  • Overall survival [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1 year survival rate, objective response rate, response duration, time to response, time to progression, tolerability, patient-perceived disease status, and well being in each treatment arm [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

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.


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts 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.
  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 identifier: NCT00320359

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

No publications provided

Responsible Party: GlaxoSmithKline Identifier: NCT00320359     History of Changes
Other Study ID Numbers: 104864-A/479
Study First Received: May 1, 2006
Last Updated: July 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors processed this record on November 25, 2014