Non Small Cell Lung CancerPhase 2NCT00582634
Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer
A Phase 2 study testing docetaxel and cisplatin in people with Non Small Cell Lung Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
To determine if docetaxel and cisplatin can be administered in a dose intense manner in the adjuvant setting in resected non-small cell lung cancer To evaluate the time to progression and overall survival To evaluate toxicities of this chemotherapy combination in the adjuvant setting To correlate XPD and ERCC1… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- docetaxel and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Dec 2007
- 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
- Stage IB to IIIA non-small cell lung cancer completely resected within 4 to 8 weeks of initiating treatment on study
- Performance Status ECOG 0 or 1
- Peripheral neuropathy: < grade 1
- Adequate blood cell counts
- Adequate liver and hepatic function
- Women of childbearing potential must have a negative pregnancy test.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter
Who cannot join
- Patients with a history of severe hypersensitivity reaction to Docetaxel® or other drugs formulated with polysorbate 80.
- Women who are breast-feeding.
- Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively)
- Uncontrolled cardiac disease or uncontrolled hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: Phase II Study of Adjuvant Cisplatin and Docetaxel in Non-small Cell Lung Cancer
- To determine if docetaxel and cisplatin can be administered in a dose intense manner in the adjuvant setting in resected non-small cell lung cancer
- To evaluate the time to progression and overall survival
- To evaluate toxicities of this chemotherapy combination in the adjuvant setting
- To correlate XPD and ERCC1 polymorphisms with time to progression and toxicities in patients treated with this regimen
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- docetaxel and cisplatin
- Keywords
- non small cell lung cancer, adjuvant, cisplatin, docetaxel
- 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.
docetaxel and cisplatinDrug
Also called Taxotere
Docetaxel (75mg/m2) followed by cisplatin (75mg/m2) on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for4 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel followed by cisplatin | Experimental | Docetaxel (75mg/m2) given IV followed by cisplatin (75mg/m2) given IV on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for 4 cycles. Receives: Drug: docetaxel and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Measured: 36 months
Overall survival
Measured: 36 months
Incidence of adverse events
Measured: Baseline to 36 months
Secondary outcomes (1)
Correlate XPD and ERCC1 polymorphisms with time to progression and toxicities
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startSep 2004
- Primary completionDec 2007
- Study completionDec 2007
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.
- More trials run by University of Wisconsin, MadisonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Traynor, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582634
- Sponsor's protocol ID
- H-2004-0248
- Other IDs
- CO04503, H-2004-0248, A534260, SMPH/MEDICINE
- Status last verified
- Sep 2015
- First submitted
- 19 Dec 2007
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Adjuvant Cisplatin and Docetaxel in Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00582634
- Acronym / sponsor ID
- H-2004-0248
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- non small cell lung cancer, adjuvant, cisplatin, docetaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 28 Dec 2007 (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.
- To determine if docetaxel and cisplatin can be administered in a dose intense manner in the adjuvant setting in resected non-small cell lung cancer
- To evaluate the time to progression and overall survival
- To evaluate toxicities of this chemotherapy combination in the adjuvant setting
- To correlate XPD and ERCC1 polymorphisms with time to progression and toxicities in patients treated with this regimen
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel followed by cisplatin | Experimental | Drug: docetaxel and cisplatinDocetaxel (75mg/m2) given IV followed by cisplatin (75mg/m2) given IV on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for 4 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Stage IB to IIIA non-small cell lung cancer completely resected within 4 to 8 weeks of initiating treatment on study
- Performance Status ECOG 0 or 1
- Peripheral neuropathy: < grade 1
- Adequate blood cell counts
- Adequate liver and hepatic function
Key exclusion criteria (4 listed)
- Patients with a history of severe hypersensitivity reaction to Docetaxel® or other drugs formulated with polysorbate 80.
- Women who are breast-feeding.
- Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively)
- Uncontrolled cardiac disease or uncontrolled hypertension
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 and cisplatinAlso: TaxotereDocetaxel (75mg/m2) followed by cisplatin (75mg/m2) on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for4 cycles. | Drug | Docetaxel followed by cisplatin |
Primary outcome
Time to progression
Time frame: 36 months
Overall survival
Time frame: 36 months
Incidence of adverse events
Time frame: Baseline to 36 months
1 secondary outcome
Correlate XPD and ERCC1 polymorphisms with time to progression and toxicities
Time frame: 36 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 19 Nov 2019.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
Anne Traynor, MD principal investigator
University of Wisconsin, Madison
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 docetaxel and cisplatin in people with Non Small Cell Lung Cancer, run by University of Wisconsin, Madison 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 7 inclusion and 4 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 19 Nov 2019. 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?
Time to progression (time frame: 36 months). The study lists 3 primary outcomes in all. 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 19 Nov 2019.