Non-small Cell Lung CancerPhase 1/2NCT00264134
Docetaxel, Irinotecan, and Carboplatin in Extensive Stage Non-Small Cell Lung Cancer
A Phase 1/2 study testing Docetaxel, Irinotecan and Carboplatin in people with Non-small Cell Lung Cancer and Extensive Stage Unresectable, run by Kentuckiana Cancer Institute at 1 site in United States.
Trial summary
Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer. Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Extensive Stage Unresectable
- What is being tested?
- Docetaxel, Irinotecan and Carboplatin
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Oct 2005
- Phase
- Phase 1/2
- 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
- 18 years or older unresectable lung cancer measurable or evaluable lesions Karnofsky PS greater than or equal to 60%
Who cannot join
- untreated CNS metastases
Trial locations and contacts
1 site in 1 country.
United States1 site
Kentuckiana Cancer Institute
Louisville, Kentucky, 40202
About this study
Official title: A Phase I/II Trial: Docetaxel, Irinotecan, and Carboplatin in the Treatment of Extensive Stage Small Cell Lung Carcinoma
Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.
Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer.
Read the detailed description
A phase I/II dose escalating study to determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.
- Being tested
- Docetaxel, Irinotecan, Carboplatin
- Keywords
- Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
IrinotecanDrug
CarboplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.
Secondary outcomes (1)
Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startJun 2003
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Kentuckiana Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Shawn Glisson, MD, Principal investigator, Kentuckiana Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264134
- Sponsor's protocol ID
- 1047791
- Other IDs
- CPTAIV-0020-339
- Status last verified
- Jan 2010
- First submitted
- 8 Dec 2005
- Last updated
- 20 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial: Docetaxel, Irinotecan, and Carboplatin in the Treatment of Extensive Stage Small Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT00264134
- Acronym / sponsor ID
- 1047791
- Keywords
- Non-Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants
- Lead sponsor
- Kentuckiana Cancer InstituteUniversity, hospital or other
- Study start
- Jun 2003
- Study completion
- Oct 2005
- First posted
- 12 Dec 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.
Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.
Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer.
Detailed description
A phase I/II dose escalating study to determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- 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 (1 listed)
- 18 years or older unresectable lung cancer measurable or evaluable lesions Karnofsky PS greater than or equal to 60%
Key exclusion criteria (1 listed)
- untreated CNS metastases
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 |
|---|---|---|
| Docetaxel | Drug | – |
| Irinotecan | Drug | – |
| Carboplatin | Drug | – |
Primary outcome
Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.
1 secondary outcome
Secondary Objective: To evaluate the dose-related toxicities of this triple regimen in patients with inoperable lung cancer.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2010.
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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.
Shawn Glisson, MD principal investigator
Kentuckiana Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Docetaxel, Irinotecan and Carboplatin in people with Non-small Cell Lung Cancer and Extensive Stage Unresectable, run by Kentuckiana Cancer Institute 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 20 Jan 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early. Results are not available in the source record.
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?
Primary Objective: To determine the maximum tolerated dose of docetaxel when given with Irinotecan and Carboplatin for the treatment of inoperable lung cancer.. 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 20 Jan 2010.