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

NCT00320359 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2017-03-01

No results posted yet for this study

Summary

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

Conditions

  • Lung Cancer, Small Cell

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2007-02-28
Completion
2007-02-28

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00320359 on ClinicalTrials.gov