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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00043927




Registration number
NCT00043927
Ethics application status
Date submitted
14/08/2002
Date registered
16/08/2002
Date last updated
21/08/2013

Titles & IDs
Public title
Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults
Scientific title
An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin as Treatment for Chemotherapy-naive Patients With Extensive Disease-Small Cell Lung Cancer.
Secondary ID [1] 0 0
104864-A/389
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - topotecan/cisplatin
Treatment: Drugs - etoposide/cisplatin

Treatment: Drugs: topotecan/cisplatin


Treatment: Drugs: etoposide/cisplatin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Secondary outcome [1] 0 0
response rates, response duration, time to progression, tolerability and patient-perceived disease status and well being for patients
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Written informed consent (patient's written understanding of and agreement to
participate in this study).

- Patients with confirmed extensive small cell lung cancer (SCLC).

- No prior chemotherapy within 5 years of the diagnosis of SCLC.

- Presence of either measurable or non-measurable SCLC by X-ray or physical examination.

- At least 3 weeks since last major surgery (a lesser period is acceptable if decided to
be in the best interest of the patient).

- At least 24 hours since prior radiotherapy. Patients who have received radiotherapy
must have recovered from any reversible side effects, such as nausea and vomiting.

- Laboratory criteria: Patients must have adequate bone marrow reserve and adequate
kidney and liver function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Symptoms of spreading of the disease to the brain that requires treatment with drugs
called steroids.

- Any active infection.

- Severe medical problems other than the diagnosis of SCLC, that would limit the ability
of the patient to follow study guidelines or that would expose the patient to extreme
risk.

- Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational
therapy for the treatment of SCLC.

- Use of an investigational drug within 30 days before the first dose of study
medication.

- Women who are pregnant or lactating.

- Patients of child-bearing potential who refuse to practice an adequate form of birth
control.

- Patients with clinical evidence of any stomach or intestinal (GI) condition.

- Patients requiring treatment with the drug cyclosporin A.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Poole

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will gather and compare data about the effectiveness and safety of two different
treatments for extensive Small Cell Lung Cancer (SCLC) in patients who have not received
previous chemotherapy. One treatment will use an investigational drug in combination with an
FDA approved chemotherapy. The other treatment will use a combination of two FDA approved
chemotherapy drugs.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00043927
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trial, MD
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00043927