Small Cell Lung CancerPhase 2NCT00294190
Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
A Phase 2 study testing Topotecan in people with Small Cell Lung Cancer and Carcinoma, Small Cell, run by SCRI Development Innovations, LLC at 13 sites in United States.
Trial summary
This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer, Carcinoma, Small Cell
- What is being tested?
- Topotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 13 sitesUnited States
- Study dates
- Feb 2006to Jul 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
- Extensive small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen
- Measurable or evaluable disease
- Able to perform activities of daily living with minimal assistance
- Adequate bone marrow, liver and kidney function
- May have received no more than 3 previous courses of radiation therapy
- Give written informed consent prior to study entry
Who cannot join
- Patients with limited stage disease
- History of a prior malignancy within three years
- Female patients who are pregnant or are breast feeding
- Significant history of uncontrolled cardiac disease
- Myocardial infarction or stroke within six months
- Symptomatic peripheral vascular disease
- CNS involvement
- Serious active infection or underlying medical condition
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Hematology Oncology Life Center
Alexandria, Louisiana, 71301
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, 37404
Oncology Hematology Care
Cincinnati, Ohio, 45242
Florida Cancer Specialists
Fort Myers, Florida, 33901
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503
Northeast Arkansas Clinic
Jonesboro, Arkansas, 72401
Watson Clinic Center for Cancer Care and Research
Lakeland, Florida, 33805
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, 40207
Tennessee Oncology, PLLC
Nashville, Tennessee, 37023
Methodist Cancer Center
Omaha, Nebraska, 68114
Florida Hospital Cancer Institute
Orlando, Florida, 32804
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
About this study
Official title: A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.
Read the detailed description
All patients will receive weekly topotecan.
Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8 weeks.)
- Conditions
- Small Cell Lung Cancer, Carcinoma, Small Cell
- Being tested
- Topotecan
- Keywords
- Lung Cancer, Extensive stage, Small Cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma, Carcinoma, Small Cell, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopotecanDrug
Also called Hycamtin
Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break.
| Study group | Role | What they receive |
|---|---|---|
| Topotecan | Experimental | Not described Receives: Drug: Topotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 18 months
Secondary outcomes (4)
overall toxicity
Measured: 18 months
time to progression
Measured: 18 months
duration of response
Measured: 18 months
overall survival
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionSep 2007
- Study completionJul 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 Small Cell 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCRI Development Innovations, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- David R. Spigel, MD, Principal investigator, SCRI Development Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294190
- Sponsor's protocol ID
- SCRI LUN 120
- Other IDs
- 105642
- Status last verified
- May 2011
- First submitted
- 16 Feb 2006
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Spigel DR, Greco FA, Burris HA 3rd, Shipley DL, Clark BL, Whorf RC, Arrowsmith ER, Hainsworth JD. A phase II study of higher dose weekly topotecan in relapsed small-cell lung cancer. Clin Lung Cancer. 2011 May;12(3):187-91. doi: 10.1016/j.cllc.2011.03.016. Epub 2011 Apr 28.
PubMed 21663862
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00294190
- Acronym / sponsor ID
- SCRI LUN 120
- Conditions
- Small Cell Lung Cancer, Carcinoma, Small Cell
- Keywords
- Lung Cancer, Extensive stage, Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- SCRI Development Innovations, LLCUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Feb 2006 (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 proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.
Detailed description
All patients will receive weekly topotecan.
Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8 weeks.)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topotecan | Experimental | Drug: Topotecan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Extensive small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen
- Measurable or evaluable disease
- Able to perform activities of daily living with minimal assistance
- Adequate bone marrow, liver and kidney function
- May have received no more than 3 previous courses of radiation therapy
Key exclusion criteria (8 listed)
- Patients with limited stage disease
- History of a prior malignancy within three years
- Female patients who are pregnant or are breast feeding
- Significant history of uncontrolled cardiac disease
- Myocardial infarction or stroke within six months
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 |
|---|---|---|
| TopotecanAlso: HycamtinTopotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. | Drug | Topotecan |
Primary outcome
Overall response rate
Time frame: 18 months
4 secondary outcomes
overall toxicity
Time frame: 18 months
time to progression
Time frame: 18 months
duration of response
Time frame: 18 months
overall survival
Time frame: 18 months
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 10 Dec 2012.
- Derived from this study: PubMed 21663862Spigel DR, Greco FA, Burris HA 3rd, Shipley DL, Clark BL, Whorf RC, Arrowsmith ER, Hainsworth JD. A phase II study of higher dose weekly topotecan in relapsed small-cell lung cancer. Clin Lung Cancer. 2011 May;12(3):187-91. doi: 10.1016/j.cllc.2011.03.016. Epub 2011 Apr 28.
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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.
David R. Spigel, MD principal investigator
SCRI Development Innovations, LLC
13 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 Small Cell Lung Cancer and Carcinoma, Small Cell, run by SCRI Development Innovations, LLC at 13 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 6 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 10 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Overall response rate (time frame: 18 months). 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 NCT00294190, 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 10 Dec 2012.