Lung CancerPhase 2NCT00193245
Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer
A Phase 2 study testing Topotecan and Docetaxel in people with Lung Cancer, run by SCRI Development Innovations, LLC at 1 site in United States.
Trial summary
In this trial we will evaluate and compare the efficacy and toxicity of oral topotecan with intravenous docetaxel in the second-line treatment of patients with non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Topotecan and Docetaxel
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2000to Jan 2009
- 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
- To be included in this study, you must meet the following criteria:
- Relapsed or Progressive Disease
- Stage IIIB (not candidate for combined modality) or IV
- No more than one prior chemotherapy regimen
- Able to perform activities of daily living without assistance
- Measurable disease outside of radiation port
- Adequate bone marrow, liver and kidney function
- Must understand study and sign informed consent prior to enrollment
Who cannot join
- You cannot participate in this study if any of the following apply to you:
- Prior treatment with Topotecan or Docetaxel
- Uncontrolled brain metastases
- Moderate peripheral neuropathy
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
About this study
Official title: A Randomized Trial of Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer
In this trial we will evaluate and compare the efficacy and toxicity of oral topotecan with intravenous docetaxel in the second-line treatment of patients with non-small cell lung cancer.
Read the detailed description
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
- Topotecan
- Docetaxel
For ever 2 patients treated, 1 will receive treatment A (Topotecan) and 1 will receive treatment B (Docetaxel). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Secondary outcomes (3)
Time to Progression
Overall survival
Overall toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startNov 2000
- Primary completionOct 2005
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Aventis Pharmaceuticals, GlaxoSmithKline
- Investigators
- Howard A. Burris, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193245
- Sponsor's protocol ID
- SCRI LUN 47
- Other IDs
- 104864-450
- Status last verified
- Jan 2009
- First submitted
- 12 Sep 2005
- Last updated
- 28 Jun 2010
- Results posted
- No
Publications
Jones S, Thompson D, Barton J, Patton J, Shipley D, Greco FA, Spigel D, Infante J, Burris HA 3rd. A randomized phase II trial of oral topotecan versus docetaxel in the second-line treatment of non-small-cell lung cancer. Clin Lung Cancer. 2008 May;9(3):154-9. doi: 10.3816/CLC.2008.n.023.
PubMed 18621625
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00193245
- Acronym / sponsor ID
- SCRI LUN 47
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- AstraZeneca, Aventis Pharmaceuticals, GlaxoSmithKline
- Study start
- Nov 2000
- Primary completion
- Oct 2005 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Sep 2005 (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.
In this trial we will evaluate and compare the efficacy and toxicity of oral topotecan with intravenous docetaxel in the second-line treatment of patients with non-small cell lung cancer.
Detailed description
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
- Topotecan
- Docetaxel
For ever 2 patients treated, 1 will receive treatment A (Topotecan) and 1 will receive treatment B (Docetaxel). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 (8 listed)
- Relapsed or Progressive Disease
- Stage IIIB (not candidate for combined modality) or IV
- No more than one prior chemotherapy regimen
- Able to perform activities of daily living without assistance
- Measurable disease outside of radiation port
Key exclusion criteria (5 listed)
- Prior treatment with Topotecan or Docetaxel
- Uncontrolled brain metastases
- Moderate peripheral neuropathy
- Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
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 | – |
| Docetaxel | Drug | – |
Primary outcome
Overall response rate
3 secondary outcomes
Time to Progression
Overall survival
Overall toxicity
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 28 Jun 2010.
- Results publication: PubMed 18621625Jones S, Thompson D, Barton J, Patton J, Shipley D, Greco FA, Spigel D, Infante J, Burris HA 3rd. A randomized phase II trial of oral topotecan versus docetaxel in the second-line treatment of non-small-cell lung cancer. Clin Lung Cancer. 2008 May;9(3):154-9. doi: 10.3816/CLC.2008.n.023.
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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.
Howard A. Burris, MD principal investigator
SCRI Development Innovations, LLC
1 site 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 and Docetaxel in people with Lung Cancer, run by SCRI Development Innovations, LLC at 1 site 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 8 inclusion and 5 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 28 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Overall response rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00193245, which also lists 1 linked publication.
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 28 Jun 2010.