Head and Neck CancerPhase 2NCT01024101
Early Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Advanced or Recurrent Head and Neck Cancer
A Phase 2 study testing Paclitaxel in people with Head and Neck Cancer, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent head and neck cancer Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with locally advanced head and neck cancer pretreated with surgery and/or radiotherapy and not suitable for further radical local treatment or patients with distant metastases who may have received no or one chemotherapy regimen
Who cannot join
- Patients with serious, uncontrolled medical illness
About this study
The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent head and neck cancer
- Conditions
- Head and Neck Cancer
- Being tested
- Paclitaxel
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol, BMS-181339
Solution, IV, 100 mg/m², Weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel | Experimental | Not described Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on predetermined evaluation criteria
Measured: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Safety: incidence and severity of adverse events, laboratory test abnormalities
Measured: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Secondary outcomes (1)
Duration of response, defined as either Complete or Partial Response, based on Evaluation Criteria on Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer
Measured: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startJan 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024101
- Sponsor's protocol ID
- CA139-372
- Status last verified
- Apr 2011
- First submitted
- 30 Nov 2009
- Last updated
- 25 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Phase II Study of Weekly Paclitaxel (BMS-181339) in Patient With Advanced or Recurrent Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT01024101
- Acronym / sponsor ID
- CA139-372
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 2 Dec 2009 (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.
The purpose of this study is to evaluate the efficacy and the safety of paclitaxel given weekly in patients with advanced or recurrent head and neck cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel | Experimental | Drug: Paclitaxel |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with locally advanced head and neck cancer pretreated with surgery and/or radiotherapy and not suitable for further radical local treatment or patients with distant metastases who may have received no or one chemotherapy regimen
Key exclusion criteria (1 listed)
- Patients with serious, uncontrolled medical illness
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 |
|---|---|---|
| PaclitaxelAlso: Taxol, BMS-181339Solution, IV, 100 mg/m², Weekly for 6 of 7 weeks, until disease progression or unacceptable toxicity became apparent | Drug | Paclitaxel |
Primary outcome
Response rate [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on predetermined evaluation criteria
Time frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
Safety: incidence and severity of adverse events, laboratory test abnormalities
Time frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity
1 secondary outcome
Duration of response, defined as either Complete or Partial Response, based on Evaluation Criteria on Therapeutic Effects in Patients with Advanced or Recurrent Breast Cancer
Time frame: Each 49 day course of treatment until withdrawal or unacceptable 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 25 Apr 2011.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel in people with Head and Neck Cancer, run by Bristol-Myers Squibb.
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: finished, as of the sponsor's last update on 25 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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 [defined as total number of patients with complete and partial response divided by number of response-evaluable patients] based on predetermined evaluation criteria (time frame: Each 49 day course of treatment until withdrawal or unacceptable toxicity). The study lists 2 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 25 Apr 2011.