Head and Neck NeoplasmsPhase 2TAX200006NCT00521521
Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer
A Phase 2 study testing docetaxel and cisplatin and docetaxel in people with Head and Neck Neoplasms, run by Sanofi at 1 site in France.
Trial summary
To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or without cisplatin in terms of objective response rates (WHO criteria). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- docetaxel and cisplatin and docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2001to May 2006
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with locally advanced head and neck cancer (T3 and T4 tumors), epidermoid, histologically proven without metastasis; the primitive site of which is the oral cavity, the oropharynx, the hypopharynx or the larynx.
- Locally advanced tumors which are inoperable, or operable but the patient refuses surgery.
- Age ≥ 18 years and ≤ 70 years.
- PS < 2.
- Satisfactory hematological, hepatic and renal functions: (PN ≥ 2000/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 10g/dl, serum creatinine ≤ 120 µmol/l or creatinine clearance ≥ 60 ml/mn, normal total bilirubin, AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN) of each center, PAL ≤ 5 x LNS; patients with AST or ALT > 1.5 x LNS combined with PAL > 2.5 x LNS will not be eligible for this trial.
Who cannot join
- Any metastases (other than cervical ganglia).
- Cancer of the cavum and the facial structure.
- Any previous chemotherapy or radiotherapy, irrespective of the reason.
- Any surgery for epidermoid carcinoma in the upper aerodigestive tracts.
- Weight loss ≥10% of total body weight during the last 3 months.
- Any other previous cancer excepting in situ or cutaneous cervical cancer (spinocellular or basocellular).
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- Pregnant or nursing women; women of childbearing potential must use an appropriate method of contraception.
- Poorly controlled progressive infection.
- Peripheral neuropathy with NCI grade ≥ 2.
- Neurological or psychiatric disease (dementia, seizures, etc.) that is not compatible with good understanding and sufficient compliance with treatment.
- Any other poorly controlled progressive disease, such as heart failure, symptomatic cardiac rhythm disorders, progressive angina pectoris, or respiratory impairment.
- Any other concomitant investigational treatment.
- Any other concomitant anticancer treatment.
- Allergy to polysorbate 80.
- Definitive formal contraindication to corticosteroids.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Phase II Study of the Combination of Docetaxel (TAXOTERE) and Concomitant Radiotherapy With or Without Cisplatin in Patients With Locally Advanced Head and Neck Cancer
To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or without cisplatin in terms of objective response rates (WHO criteria).
- Conditions
- Head and Neck Neoplasms
- Being tested
- docetaxel and cisplatin, docetaxel
- 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.
docetaxel and cisplatinDrug
docetaxelDrug
| Study group | Role | What they receive |
|---|---|---|
| docetaxel and cisplatin | Active comparator | Not described Receives: Drug: docetaxel and cisplatin |
| docetaxel | Experimental | Not described Receives: Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rates
Measured: evaluated 8 weeks after the end of radiotherapy
Secondary outcomes (1)
Duration of the responses and overall survival
Measured: time until progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startJul 2001
- Primary completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marie SEBILLE, Dr., Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521521
- Sponsor's protocol ID
- TAX_FR1_236
- Acronym
- TAX200006
- Status last verified
- Dec 2009
- First submitted
- 27 Aug 2007
- Last updated
- 7 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Phase II Study of the Combination of Docetaxel (TAXOTERE) and Concomitant Radiotherapy With or Without Cisplatin in Patients With Locally Advanced Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00521521
- Acronym / sponsor ID
- TAX200006 / TAX_FR1_236
- Conditions
- Head and Neck Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Jul 2001
- Primary completion
- May 2006 (actual)
- First posted
- 28 Aug 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 evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or without cisplatin in terms of objective response rates (WHO criteria).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| docetaxel and cisplatin | Active comparator | Drug: docetaxel and cisplatin |
| docetaxel | Experimental | Drug: docetaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with locally advanced head and neck cancer (T3 and T4 tumors), epidermoid, histologically proven without metastasis; the primitive site of which is the oral cavity, the oropharynx, the hypopharynx or the larynx.
- Locally advanced tumors which are inoperable, or operable but the patient refuses surgery.
- Age ≥ 18 years and ≤ 70 years.
- PS < 2.
- Satisfactory hematological, hepatic and renal functions: (PN ≥ 2000/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 10g/dl, serum creatinine ≤ 120 µmol/l or creatinine clearance ≥ 60 ml/mn, normal total bilirubin, AST (SGOT) and ALT (SGPT) ≤ 2.5 x the upper limit of normal (ULN) of each center, PAL ≤ 5 x LNS; patients with AST or ALT > 1.5 x LNS combined with PAL > 2.5 x LNS will not be eligible for this trial.
Key exclusion criteria (16 listed)
- Any metastases (other than cervical ganglia).
- Cancer of the cavum and the facial structure.
- Any previous chemotherapy or radiotherapy, irrespective of the reason.
- Any surgery for epidermoid carcinoma in the upper aerodigestive tracts.
- Weight loss ≥10% of total body weight during the last 3 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 |
|---|---|---|
| docetaxel and cisplatin | Drug | docetaxel and cisplatin |
| docetaxel | Drug | docetaxel |
Primary outcome
Objective response rates
Time frame: evaluated 8 weeks after the end of radiotherapy
1 secondary outcome
Duration of the responses and overall survival
Time frame: time until progression
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 7 Dec 2009.
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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.
Marie SEBILLE, Dr. study director
Sanofi
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 and docetaxel in people with Head and Neck Neoplasms, run by Sanofi at 1 site in France.
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 5 inclusion and 16 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 7 Dec 2009. 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 France. 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?
Objective response rates (time frame: evaluated 8 weeks after the end of radiotherapy). 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 7 Dec 2009.