Lung Cancer, Small CellPhase 2(SCLC)NCT00043862
The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)
A Phase 2 study testing topotecan in people with Lung Cancer, Small Cell and Small Cell Lung Cancer, run by GlaxoSmithKline at 31 sites in United States.
Trial summary
This study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Small Cell, Small Cell Lung Cancer
- What is being tested?
- topotecan
- How many people
- 60 participants
- Where
- 31 sitesUnited States
- Study dates
- Aug 2002to Nov 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have newly diagnosed, limited stage SCLC (small cell lung cancer), with no prior radiotherapy. Patients are allowed to have had a resection or biopsy.
- Women of reproductive potential must have a negative serum pregnancy test at the study screening visit.
- Patients must give written informed consent to participate in the study.
- Patients must be able to take oral medication.
- Patients should be completely recovered from recent surgery.
- Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.
- Patients must be evaluated by the radiation oncologist prior to study entry.
Who cannot join
- Extensive Stage SCLC.
- Women who are pregnant or lactating.
- Use of an investigational drug within 30 days prior to the first dose of study medication.
- Any medically/clinically significant active infection.
- Symptoms of the SCLC spreading to the brain.
- Patients with limited stage SCLC who have undergone complete resection with no measurable disease prior to starting chemotherapy.
- Severe medical problems, unrelated to SCLC, that would limit the patient's full ability to follow all study rules and procedures, or that would expose the patient to extreme risk.
- Other ongoing, immunotherapy or radiotherapy being administered at the time as study participation.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
GSK Investigational Site
Akron, Ohio, 44304
GSK Investigational Site
Albuquerque, New Mexico, 87109
GSK Investigational Site
Bakersfield, California, 93309
GSK Investigational Site
Cincinnati, Ohio, 45236
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Duluth, Minnesota, 55805
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Fountain Valley, California, 92708
GSK Investigational Site
Gainesville, Florida, 32610
GSK Investigational Site
Green Bay, Wisconsin, 54301
GSK Investigational Site
Indianapolis, Indiana, 46260
GSK Investigational Site
La Crosse, Wisconsin, 54601
GSK Investigational Site
Lexington, Kentucky, 40536-0098
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Los Angeles, California, 90057
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Milwaukee, Wisconsin, 53215
GSK Investigational Site
Minneapolis, Minnesota, 55455
GSK Investigational Site
New Orleans, Louisiana, 70112
GSK Investigational Site
New Orleans, Louisiana, 70121
GSK Investigational Site
Phoenix, Arizona, 85013 - 4496
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Robbinsdale, Minnesota, 55422
GSK Investigational Site
Saint Louis, Montana, 63110
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Scarborough, Maine, 04074
GSK Investigational Site
Shreveport, Louisiana, 71103
GSK Investigational Site
Springfield, Massachusetts, 01107
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Toledo, Ohio, 43614-5809
GSK Investigational Site
Wausau, Wisconsin, 54401
About this study
Official title: A Phase II Trial of Twice Daily Oral Topotecan as a Radiation Sensitizer With Twice Daily Radiotherapy for Newly Diagnosed Small Cell Lung Cancer
This study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. Study patients will receive two additional courses of the standard chemotherapy combination after completing radiation therapy.
- Conditions
- Lung Cancer, Small Cell, Small Cell Lung Cancer
- Being tested
- topotecan
- Keywords
- Hycamtin, oral, Radiation Sensitization, Small Cell Lung Cancer, newly diagnosed, limited stage, topotecan
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topotecanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Secondary outcomes (1)
Time to Progression, response duration, survival, quantitative and qualitative assessment of tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2002 (estimated)
- Study startAug 2002
- Primary completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Small CellStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043862
- Sponsor's protocol ID
- 104864/535
- Acronym
- (SCLC)
- Status last verified
- Mar 2013
- First submitted
- 14 Aug 2002
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Twice Daily Oral Topotecan as a Radiation Sensitizer With Twice Daily Radiotherapy for Newly Diagnosed Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00043862
- Acronym / sponsor ID
- (SCLC) / 104864/535
- Conditions
- Lung Cancer, Small Cell, Small Cell Lung Cancer
- Keywords
- Hycamtin, oral, Radiation Sensitization, Small Cell Lung Cancer, newly diagnosed, limited stage, topotecan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Nov 2005 (actual)
- First posted
- 15 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. Study patients will receive two additional courses of the standard chemotherapy combination after completing radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have newly diagnosed, limited stage SCLC (small cell lung cancer), with no prior radiotherapy. Patients are allowed to have had a resection or biopsy.
- Women of reproductive potential must have a negative serum pregnancy test at the study screening visit.
- Patients must give written informed consent to participate in the study.
- Patients must be able to take oral medication.
- Patients should be completely recovered from recent surgery.
Key exclusion criteria (8 listed)
- Extensive Stage SCLC.
- Women who are pregnant or lactating.
- Use of an investigational drug within 30 days prior to the first dose of study medication.
- Any medically/clinically significant active infection.
- Symptoms of the SCLC spreading to the brain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topotecan | Drug | – |
Primary outcome
Response rate
1 secondary outcome
Time to Progression, response duration, survival, quantitative and qualitative assessment of tolerability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MD study director
GlaxoSmithKline
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing topotecan in people with Lung Cancer, Small Cell and Small Cell Lung Cancer, run by GlaxoSmithKline at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2017.