Cancer of Head and NeckPhase 1/2NCT00318890
Cisplatin and Docetaxel Plus Docetaxel and Radiotherapy With Amifostine for Squamous Cell Carcinoma of the Head and Neck
A Phase 1/2 study testing Cisplatin, Docetaxel and Radiotherapy in people with Cancer of Head and Neck and Head Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This trial seeks to accomplish both local and regional control of head and neck cancer and reduce systemic metastatic disease. To do this, patients will received chemotherapy followed by chemotherapy and radiation (given together) with an escalating dose of docetaxel. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cancer of Head and Neck, Head Cancer, Head and Neck Cancer
- What is being tested?
- Cisplatin, Docetaxel and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Dec 2007
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient has histologically proven primary or recurrent squamous cell carcinoma arising in the oropharynx, oral cavity, hypopharynx, larynx, or nasopharynx.
- The patient has stage III or IV disease.
- Performance status < 2 (ECOG scale) with a life expectancy of > 12 months.
- Age 19 years and above.
- The patient is medically fit to tolerate a course of definitive radiation therapy.
- The patient has:
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- adequate hepatic function with bilirubin < upper limit of normal (ULN)
- transaminases (SGOT and SGPT) may be up to 2.5 x ULN if alkaline phosphatase is < ULN, or alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN
- adequate renal function with serum creatinine < 1.5 mg/dl (or estimated creatinine clearance of > 50 mL/min)
- normal serum calcium
- adequate hematologic function as: defined by an absolute neutrophil count > 1500/ml, hemoglobin > 8.0 g/dl, and platelet count > 100,000/ml.
- The patient may have had a prior malignancy but must be three years from treatment.
- A history of superficial non-melanoma skin cancer or in situ carcinoma of the cervix less then three years will be allowed.
- The patient must agree to use effective contraception if procreative potential exists, and continue contraception for at least 6 months following completion of the study.
- Patient must sign informed consent.
Who cannot join
- The patient has received radiation therapy previously to the head and neck.
- The patient has received prior chemotherapy for head and neck cancer.
- The patient is pregnant or lactating.
- Peripheral neuropathy > Grade 2.
- Serious non-malignant disease (e.g. congestive heart failure, uncontrolled atrial fibrillation, active hepatitis).
- Any underlying psychological condition that would prohibit the understanding and rendering of informed consent.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: A Phase I/II Trial of Induction Cisplatin and Docetaxel Followed by Concomitant Docetaxel/Radiotherapy With Subcutaneous Amifostine for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
This trial seeks to accomplish both local and regional control of head and neck cancer and reduce systemic metastatic disease. To do this, patients will received chemotherapy followed by chemotherapy and radiation (given together) with an escalating dose of docetaxel.
Read the detailed description
The majority of head and neck cancer patients present with more advanced stages III or IV disease. The treatment of cancers of the head and neck can have profound consequences with regard to functional abilities such as speech and eating. In the treatment of both locally advanced HNSCC and sites where organ preservation is desirable, radiation therapy has been a major method of treatment. However, as a single modality, radiation therapy can cure fewer than 30% of patients with advanced disease. Attempts to improve the outcome of locally advanced HNSCC have generally added chemotherapy to radiotherapy. However, the optimal manner to integrate chemotherapy into the plan of care has been controversial. Chemotherapy has been used most commonly as either induction therapy preceding radiation, or more recently as concomitant therapy along with radiation. Induction chemotherapy has been associated with high response rates of 60-90%, but no significant change in loco-regional control or survival.Clinical trials incorporating chemotherapy with concurrent radiation have recently generated considerable interest. To accomplish both loco-regional control and reduce systemic metastasis, this trial proposes induction chemotherapy followed by concomitant chemotherapy-radiation with an escalating dose of docetaxel in patients with locally advanced previously untreated HNSCC.
- Keywords
- Chemotherapy and Radiotherapy for Head and Neck Cancer, Chemotherapy, Radiotherapy Squamous Cell Carcinoma Head Neck
- 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.
CisplatinDrug
Also called Platinol-AQ
Cisplatin is given at a dose of 75 mg/m2 intravenously for three cycles on Days 1, 21, and 43.
DocetaxelDrug
Also called Taxotere
Docetaxel is given at a dose of 75 mg/m2 intravenously on Days 1, 21, and 43 and continued at variable doses for 4 weeks with standard radiotherapy.
RadiotherapyProcedure or surgery
Radiation therapy will be given 5 days each week for 4 weeks plus a concomitant boost in the last 2 weeks of treatment to deliver 54 Gy in 30 fractions. Radiotherapy will follow the induction chemotherapy with docetaxel and cisplatin.
AmifostineDrug
Also called Ethyol
Amifostine will be administered as a subcutaneous injection on a daily basis during radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel + cisplatin followed by radiation | Experimental | Docetaxel with cisplatin is given for three cycles, followed by concomitant therapy with weekly docetaxel for 4 weeks. Radiation therapy is given 5 days each week on Days 64-106 with a concomitant boost in the last 2 weeks of treatment. Amifostine is given as an injection on a daily basis during radiotherapy. Receives: Drug: Cisplatin; Drug: Docetaxel; Procedure: Radiotherapy; Drug: Amifostine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the response rate to chemotherapy followed by docetaxel with radiotherapy and to assess overall survival, local-regional recurrence rate and effects on the quality of life.
Measured: approximately 4 months
Secondary outcomes (3)
To evaluate the toxicities of chemotherapy followed by concomitant docetaxel with radiotherapy in patients.
Measured: approximately 4 months
To evaluate tumor specimens for intermediary biomarkers of response or prognosis as compared to normal tissue
Measured: approximately 4 months
To assess the tolerance to subcutaneous amifostine and its effect on saliva production.
Measured: approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startOct 2002
- Primary completionApr 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 Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Responsible party
- Principal investigator, Lisle Nabell, University of Alabama at Birmingham
- Investigators
- Lisle Nabell, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318890
- Sponsor's protocol ID
- F020522012
- Other IDs
- UAB 0210
- Status last verified
- Feb 2019
- First submitted
- 25 Apr 2006
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Trial of Induction Cisplatin and Docetaxel Followed by Concomitant Docetaxel/Radiotherapy With Subcutaneous Amifostine for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT00318890
- Acronym / sponsor ID
- F020522012
- Keywords
- Chemotherapy and Radiotherapy for Head and Neck Cancer, Chemotherapy, Radiotherapy Squamous Cell Carcinoma Head Neck
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals
- Study start
- Oct 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 27 Apr 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.
This trial seeks to accomplish both local and regional control of head and neck cancer and reduce systemic metastatic disease. To do this, patients will received chemotherapy followed by chemotherapy and radiation (given together) with an escalating dose of docetaxel.
Detailed description
The majority of head and neck cancer patients present with more advanced stages III or IV disease. The treatment of cancers of the head and neck can have profound consequences with regard to functional abilities such as speech and eating. In the treatment of both locally advanced HNSCC and sites where organ preservation is desirable, radiation therapy has been a major method of treatment. However, as a single modality, radiation therapy can cure fewer than 30% of patients with advanced disease. Attempts to improve the outcome of locally advanced HNSCC have generally added chemotherapy to radiotherapy. However, the optimal manner to integrate chemotherapy into the plan of care has been controversial. Chemotherapy has been used most commonly as either induction therapy preceding radiation, or more recently as concomitant therapy along with radiation. Induction chemotherapy has been associated with high response rates of 60-90%, but no significant change in loco-regional control or survival.Clinical trials incorporating chemotherapy with concurrent radiation have recently generated considerable interest. To accomplish both loco-regional control and reduce systemic metastasis, this trial proposes induction chemotherapy followed by concomitant chemotherapy-radiation with an escalating dose of docetaxel in patients with locally advanced previously untreated HNSCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Docetaxel + cisplatin followed by radiation | Experimental | Drug: Cisplatin, Drug: Docetaxel, Procedure: Radiotherapy, Drug: AmifostineDocetaxel with cisplatin is given for three cycles, followed by concomitant therapy with weekly docetaxel for 4 weeks. Radiation therapy is given 5 days each week on Days 64-106 with a concomitant boost in the last 2 weeks of treatment. Amifostine is given as an injection on a daily basis during radiotherapy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The patient has histologically proven primary or recurrent squamous cell carcinoma arising in the oropharynx, oral cavity, hypopharynx, larynx, or nasopharynx.
- The patient has stage III or IV disease.
- Performance status < 2 (ECOG scale) with a life expectancy of > 12 months.
- Age 19 years and above.
- The patient is medically fit to tolerate a course of definitive radiation therapy.
Key exclusion criteria (7 listed)
- The patient has received radiation therapy previously to the head and neck.
- The patient has received prior chemotherapy for head and neck cancer.
- The patient is pregnant or lactating.
- Peripheral neuropathy > Grade 2.
- Serious non-malignant disease (e.g. congestive heart failure, uncontrolled atrial fibrillation, active hepatitis).
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 |
|---|---|---|
| CisplatinAlso: Platinol-AQCisplatin is given at a dose of 75 mg/m2 intravenously for three cycles on Days 1, 21, and 43. | Drug | Docetaxel + cisplatin followed by radiation |
| DocetaxelAlso: TaxotereDocetaxel is given at a dose of 75 mg/m2 intravenously on Days 1, 21, and 43 and continued at variable doses for 4 weeks with standard radiotherapy. | Drug | Docetaxel + cisplatin followed by radiation |
| RadiotherapyRadiation therapy will be given 5 days each week for 4 weeks plus a concomitant boost in the last 2 weeks of treatment to deliver 54 Gy in 30 fractions. Radiotherapy will follow the induction chemotherapy with docetaxel and cisplatin. | Procedure or surgery | Docetaxel + cisplatin followed by radiation |
| AmifostineAlso: EthyolAmifostine will be administered as a subcutaneous injection on a daily basis during radiotherapy. | Drug | Docetaxel + cisplatin followed by radiation |
Primary outcome
To establish the response rate to chemotherapy followed by docetaxel with radiotherapy and to assess overall survival, local-regional recurrence rate and effects on the quality of life.
Time frame: approximately 4 months
3 secondary outcomes
To evaluate the toxicities of chemotherapy followed by concomitant docetaxel with radiotherapy in patients.
Time frame: approximately 4 months
To evaluate tumor specimens for intermediary biomarkers of response or prognosis as compared to normal tissue
Time frame: approximately 4 months
To assess the tolerance to subcutaneous amifostine and its effect on saliva production.
Time frame: approximately 4 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 5 Feb 2019.
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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.
Lisle Nabell, M.D. principal investigator
University of Alabama at Birmingham
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 Cisplatin, Docetaxel and Radiotherapy in people with Cancer of Head and Neck and Head Cancer, run by University of Alabama at Birmingham 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 15 inclusion and 7 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 5 Feb 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 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 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?
To establish the response rate to chemotherapy followed by docetaxel with radiotherapy and to assess overall survival, local-regional recurrence rate and effects on the quality of life. (time frame: approximately 4 months). 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 5 Feb 2019.