Head and Neck CancerPhase 2/3NCT00337532
A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer
A Phase 2/3 study testing Paclitaxel and cisplatin in people with Head and Neck Cancer, run by Bristol-Myers Squibb at 2 sites in South Korea.
Trial summary
The purpose of this clinical research study is to learn if a paclitaxel-cisplatin combination regimen given in the neoadjuvant setting is active in locally advanced head and neck cancer. the safety of this treatment will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Paclitaxel and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSouth Korea
- Study dates
- May 2005to Jun 2007
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Locally advanced, Stage II-IV (except M1), hand and neck cancer
- > = 1 measurable lesion
- not been previously treated for head and neck cancer
Who cannot join
- history of another malignancy
- organ allografts
- pre-exiting neuropathy > = CTC grade 2
Trial locations and contacts
2 sites in 1 country.
About this study
The purpose of this clinical research study is to learn if a paclitaxel-cisplatin combination regimen given in the neoadjuvant setting is active in locally advanced head and neck cancer. the safety of this treatment will also be studied.
- Conditions
- Head and Neck Cancer
- Being tested
- Paclitaxel, cisplatin
- 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
Sterile solution mixed with 0.9% saline or 5% glucose solution 500mL, 3-hour Continuous infusion, Level 0: 175 mg/m2, Level 1: 140 mg/m2, Level 2: 105 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.
cisplatinDrug
solution mixed with 0.9% saline 500mL, 30 to 90 min intravenous infusion, Level 0: 75 mg/m2, Level 1: 60 mg/m2, Level 2: 45 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days.
| Study group | Role | What they receive |
|---|---|---|
| paclitaxel-cisplatin combination regimen | Active comparator | Not described Receives: Drug: Paclitaxel; Drug: cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate of locally advanced head and neck cancer to a paclitaxel-cisplatin combination regimen in a neoadjuvant setting and administered during maximum 3 cycles.
Secondary outcomes (1)
Toxicity for maximum 3 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study startMay 2005
- Primary completionJun 2007
- Study completionJun 2007
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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
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
- NCT00337532
- Sponsor's protocol ID
- CA139-384
- Status last verified
- Jun 2008
- First submitted
- 14 Jun 2006
- Last updated
- 4 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00337532
- Acronym / sponsor ID
- CA139-384
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 16 Jun 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.
The purpose of this clinical research study is to learn if a paclitaxel-cisplatin combination regimen given in the neoadjuvant setting is active in locally advanced head and neck cancer. the safety of this treatment will also be studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paclitaxel-cisplatin combination regimen | Active comparator | Drug: Paclitaxel, Drug: cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Locally advanced, Stage II-IV (except M1), hand and neck cancer
- > = 1 measurable lesion
- not been previously treated for head and neck cancer
Key exclusion criteria (3 listed)
- history of another malignancy
- organ allografts
- pre-exiting neuropathy > = CTC grade 2
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 |
|---|---|---|
| PaclitaxelSterile solution mixed with 0.9% saline or 5% glucose solution 500mL, 3-hour Continuous infusion, Level 0: 175 mg/m2, Level 1: 140 mg/m2, Level 2: 105 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days. | Drug | paclitaxel-cisplatin combination regimen |
| cisplatinsolution mixed with 0.9% saline 500mL, 30 to 90 min intravenous infusion, Level 0: 75 mg/m2, Level 1: 60 mg/m2, Level 2: 45 mg/m2 (dose reduction in function of toxicity), Day 1 of each cycle, max of 3 cycles; each cycle of 21 days ± 3 days. | Drug | paclitaxel-cisplatin combination regimen |
Primary outcome
Tumor response rate of locally advanced head and neck cancer to a paclitaxel-cisplatin combination regimen in a neoadjuvant setting and administered during maximum 3 cycles.
1 secondary outcome
Toxicity for maximum 3 cycles
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 4 Feb 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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Paclitaxel and cisplatin in people with Head and Neck Cancer, run by Bristol-Myers Squibb at 2 sites in South Korea.
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 3 inclusion and 3 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 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Tumor response rate of locally advanced head and neck cancer to a paclitaxel-cisplatin combination regimen in a neoadjuvant setting and administered during maximum 3 cycles.. 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 4 Feb 2010.