Head and Neck CancerPhase 1NCT00113347
Erlotinib and Docetaxel With Concomitant Boost Radiation Therapy (XRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)
A Phase 1 study testing Erlotinib, Docetaxel and Radiation Therapy in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find the highest safe dose of the drugs OSI-774 and docetaxel that can be given together along with radiation treatment for advanced head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Erlotinib, Docetaxel and Radiation Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Apr 2011
- Phase
- Phase 1
- 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
- Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
- Patients should have stage III or IV disease, staged T3-4 and/or N2-3, M0
- Patients must have a Karnofsky performance status of >= 70
- Age >/= 18 years
- No hematogenous metastatic disease
- Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 1500 cells/mm3 and platelet count of > 100,000 cells/mm3; adequate hepatic function with total bilirubin <= Upper Limit of Normal (ULN), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) may be up to 2.5 times the upper limit of normal if alkaline phosphatase is normal. Alkaline phosphatase may be up to 4 * ULN if aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) are normal. Patients who have SGPT > 1.5 ULN and alkaline phosphatase > 2.5 * ULN are not eligible.
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- Creatinine clearance > 50 ml/min determined by 24 hour collection or nomogram: CrCl male = (140 - age) * (weight as kg)/serum Cr * 72 CrCl female = 0.85 * (CrCl male)
- Patients must not have received previous surgery, other than diagnostic biopsy, or radiation, for this cancer. Patients may have received neoadjuvant chemotherapy which must have been completed > 3 weeks from beginning therapy on this trial.
- Patients with a history of non-melanoma skin cancer, or other previous malignancies treated 5 years or more prior to the current tumor from which the patient has remained continually disease-free, are eligible.
- Patients must sign a study-specific informed consent form.
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for 6 months thereafter. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation or bilateral oophorectomy.
Who cannot join
- Histology other than squamous cell carcinoma.
- Evidence of metastases (below the clavicle or distant) by clinical or radiographic means.
- Karnofsky performance status < 70
- Prior therapy with inhibitors of epidermal growth factor receptor (EGFR)
- Prior radiotherapy to the head and neck
- Patients with simultaneous primaries
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- Patients with a past history of malignancy (excluding non melanoma skin cancers, and cancers treated > 5 years prior for which patient remains continuously disease free).
- Pregnant/breast-feeding women are ineligible.
- Patients refusing or unable to sign the informed consent.
- Patients with pre-existing peripheral neuropathy NCI Common Toxicity Criteria (CTC) grade 2 or worse.
- Patients with a history of severe hypersensitivity reaction to Taxotere® and/or Polysorbate 80 must be excluded.
- Patients may not use ketoconazole, St. John's Wort, or erythromycin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Evaluation of Erlotinib and Docetaxel With Concomitant Boost Radiation for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck
The goal of this clinical research study is to find the highest safe dose of the drugs OSI-774 and docetaxel that can be given together along with radiation treatment for advanced head and neck cancer.
Read the detailed description
OSI-774 (also known as Erlotinib or Tarceva) is a drug that helps to block the activity of an enzyme that is believed to play an important role in cell growth. It is hoped that blocking this enzyme will slow tumor growth. Docetaxel (Taxotere) is a commonly used chemotherapy drug. Docetaxel is designed to target and destroy cancer cells.
Before beginning treatment, you will have a complete physical exam. You will also have routine blood (about 4 teaspoons) and urine tests, a chest x-ray or CT scan, and an electrocardiogram (ECG - test to measure the electrical activity of the heart). You will have a dental exam performed by a dentist. Women who are able to have children must have a negative pregnancy test (blood or urine). You will also have either a CT scan or a MRI to measure your disease. You may have a bone scan and/or CT scans of your abdomen and chest if your doctor thinks it is necessary for your care.
You will have a swallowing evaluation. The swallowing evaluation involves drinking barium and other liquids of varying thickness while fluoroscopy (like an x-ray movie) is done to evaluate swallowing function. You will also complete a questionnaire that asks questions about quality of life issues. The questionnaire should take about 10 minutes to complete.
In this study you will receive radiation therapy 5 days per week (Monday through Friday) for 6 weeks. You will not receive radiation therapy on weekends. For the first 3 weeks of treatment you will receive radiation once a day. Starting on the 4th week of treatment, you will receive radiation treatment twice a day. The treatments will be at least 6 hours apart. You will receive these twice daily radiation treatments Monday through Friday for 3 weeks.
On your first day of radiation treatment you will also receive your first dose of docetaxel. You will receive docetaxel by vein over 15 to 30 minutes on Days 1, 8, 15, and 22 of treatment.
Beginning on Day 2 of treatment, you will begin taking OSI-774 by mouth. You will take OSI-774 once a day in the morning with up to 7 ounces of water either 2 hours after or 1 hour before eating. If you are unable to swallow the OSI-774, you may dissolve it in distilled water and take it through a feeding tube. You will take OSI-774 every day while on treatment except on days on which you receive docetaxel (i.e., Days 1, 8, 15, and 22). You should not take OSI-774 on days you receive a docetaxel infusion.
Participants will enter this study in groups of 3. The doses of both OSI-774 and docetaxel will be increased after each group. Six patients will be studied at the dose level that is estimated to be the highest safe dose.
While receiving treatment on this study, you will be examined at least once a week. You will also have weekly blood tests (2-4 teaspoons). At the end of treatment, you will have another CT scan or MRI to measure your disease. You will also have a complete physical exam and blood tests (4 teaspoons). You may be taken off study if your disease gets worse or intolerable side effects occur.
After completing treatment, you will have a follow-up visit every 3 months for 2 years, then every 4 months during Year 3, and every 6 months during Years 4 and 5. These visits will include a medical history and physical exam. A CT or MRI study and blood work (2-4 teaspoons) may also be done. You will have swallowing evaluations at 3 and 12 months following treatment, and then once yearly through year 5. When you have these swallowing evaluations, you will also be asked to complete a short questionnaire about swallowing. The questionnaire will take about 10 minutes to complete.
This is an investigational study. OSI-774 is approved by the FDA for treatment of non-small cell lung cancer. Docetaxel is approved by the FDA for treatment of lung cancer and breast cancer. Their use together in this study with radiation treatment is experimental. Up to 24 patients are expected to take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Squamous Cell Carcinoma, Erlotinib, Docetaxel, Radiation, Radiotherapy, Concomitant Boost Radiation
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErlotinibDrug
Also called Tarceva, OSI-774, Erlotinib Hydrochloride
Beginning on Day 2 of treatment, 100, 125, or 150 mg by mouth once a day every day while on treatment, except on days docetaxel is received.
DocetaxelDrug
Also called Taxotere
15 mg/m^2 or 20 mg/m^2 by vein over 15 to 30 minutes on Days 1, 8, 15, and 22 of treatment.
Radiation TherapyRadiation
Also called XRT, Radiotherapy
Radiation therapy to head/neck beginning on day 1 of treatment once daily 5 times per week (Monday through Friday), delivered in 40 fractions.
| Study group | Role | What they receive |
|---|---|---|
| Erlotinib + Docetaxel | Experimental | Erlotinib 100, 125, or 150 mg orally daily except days receive Docetaxel 15 mg/m^2 or 20 mg/m^2 intravenously with Concomitant Boost Radiation to Head/Neck Receives: Drug: Erlotinib; Drug: Docetaxel; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of erlotinib and docetaxel during concomitant boost radiation
MTD defined as highest dose level in which 6 patients have been treated with less than or equal to 2 instances of Dose-limiting toxicity (DLT) from 2 sources: 1) Out-of-field toxicity from unirradiated sites secondary to systemic therapy(erlotinib and docetaxel); 2) In-field toxicity from irradiated sites secondary to combined treatment.
Measured: 6 weeks of treatment, followed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2005 (estimated)
- Study startApr 2005
- Primary completionApr 2011
- Study completionApr 2011
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 M.D. Anderson Cancer CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Bonnie S. Glisson, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00113347
- Sponsor's protocol ID
- 2003-1049
- Status last verified
- Feb 2012
- First submitted
- 7 Jun 2005
- Last updated
- 27 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation of Erlotinib and Docetaxel With Concomitant Boost Radiation for Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT00113347
- Acronym / sponsor ID
- 2003-1049
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Squamous Cell Carcinoma, Erlotinib, Docetaxel, Radiation, Radiotherapy, Concomitant Boost Radiation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Aventis Pharmaceuticals, Genentech, Inc.
- Study start
- Apr 2005
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 8 Jun 2005 (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 goal of this clinical research study is to find the highest safe dose of the drugs OSI-774 and docetaxel that can be given together along with radiation treatment for advanced head and neck cancer.
Detailed description
OSI-774 (also known as Erlotinib or Tarceva) is a drug that helps to block the activity of an enzyme that is believed to play an important role in cell growth. It is hoped that blocking this enzyme will slow tumor growth. Docetaxel (Taxotere) is a commonly used chemotherapy drug. Docetaxel is designed to target and destroy cancer cells.
Before beginning treatment, you will have a complete physical exam. You will also have routine blood (about 4 teaspoons) and urine tests, a chest x-ray or CT scan, and an electrocardiogram (ECG - test to measure the electrical activity of the heart). You will have a dental exam performed by a dentist. Women who are able to have children must have a negative pregnancy test (blood or urine). You will also have either a CT scan or a MRI to measure your disease. You may have a bone scan and/or CT scans of your abdomen and chest if your doctor thinks it is necessary for your care.
You will have a swallowing evaluation. The swallowing evaluation involves drinking barium and other liquids of varying thickness while fluoroscopy (like an x-ray movie) is done to evaluate swallowing function. You will also complete a questionnaire that asks questions about quality of life issues. The questionnaire should take about 10 minutes to complete.
In this study you will receive radiation therapy 5 days per week (Monday through Friday) for 6 weeks. You will not receive radiation therapy on weekends. For the first 3 weeks of treatment you will receive radiation once a day. Starting on the 4th week of treatment, you will receive radiation treatment twice a day. The treatments will be at least 6 hours apart. You will receive these twice daily radiation treatments Monday through Friday for 3 weeks.
On your first day of radiation treatment you will also receive your first dose of docetaxel. You will receive docetaxel by vein over 15 to 30 minutes on Days 1, 8, 15, and 22 of treatment.
Beginning on Day 2 of treatment, you will begin taking OSI-774 by mouth. You will take OSI-774 once a day in the morning with up to 7 ounces of water either 2 hours after or 1 hour before eating. If you are unable to swallow the OSI-774, you may dissolve it in distilled water and take it through a feeding tube. You will take OSI-774 every day while on treatment except on days on which you receive docetaxel (i.e., Days 1, 8, 15, and 22). You should not take OSI-774 on days you receive a docetaxel infusion.
Participants will enter this study in groups of 3. The doses of both OSI-774 and docetaxel will be increased after each group. Six patients will be studied at the dose level that is estimated to be the highest safe dose.
While receiving treatment on this study, you will be examined at least once a week. You will also have weekly blood tests (2-4 teaspoons). At the end of treatment, you will have another CT scan or MRI to measure your disease. You will also have a complete physical exam and blood tests (4 teaspoons). You may be taken off study if your disease gets worse or intolerable side effects occur.
After completing treatment, you will have a follow-up visit every 3 months for 2 years, then every 4 months during Year 3, and every 6 months during Years 4 and 5. These visits will include a medical history and physical exam. A CT or MRI study and blood work (2-4 teaspoons) may also be done. You will have swallowing evaluations at 3 and 12 months following treatment, and then once yearly through year 5. When you have these swallowing evaluations, you will also be asked to complete a short questionnaire about swallowing. The questionnaire will take about 10 minutes to complete.
This is an investigational study. OSI-774 is approved by the FDA for treatment of non-small cell lung cancer. Docetaxel is approved by the FDA for treatment of lung cancer and breast cancer. Their use together in this study with radiation treatment is experimental. Up to 24 patients are expected to take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erlotinib + Docetaxel | Experimental | Drug: Erlotinib, Drug: Docetaxel, Radiation: Radiation TherapyErlotinib 100, 125, or 150 mg orally daily except days receive Docetaxel 15 mg/m^2 or 20 mg/m^2 intravenously with Concomitant Boost Radiation to Head/Neck |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histological proof (from the primary lesion and/or lymph nodes) of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
- Patients should have stage III or IV disease, staged T3-4 and/or N2-3, M0
- Patients must have a Karnofsky performance status of >= 70
- Age >/= 18 years
- No hematogenous metastatic disease
Key exclusion criteria (12 listed)
- Histology other than squamous cell carcinoma.
- Evidence of metastases (below the clavicle or distant) by clinical or radiographic means.
- Karnofsky performance status < 70
- Prior therapy with inhibitors of epidermal growth factor receptor (EGFR)
- Prior radiotherapy to the head and neck
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 |
|---|---|---|
| ErlotinibAlso: Tarceva, OSI-774, Erlotinib HydrochlorideBeginning on Day 2 of treatment, 100, 125, or 150 mg by mouth once a day every day while on treatment, except on days docetaxel is received. | Drug | Erlotinib + Docetaxel |
| DocetaxelAlso: Taxotere15 mg/m^2 or 20 mg/m^2 by vein over 15 to 30 minutes on Days 1, 8, 15, and 22 of treatment. | Drug | Erlotinib + Docetaxel |
| Radiation TherapyAlso: XRT, RadiotherapyRadiation therapy to head/neck beginning on day 1 of treatment once daily 5 times per week (Monday through Friday), delivered in 40 fractions. | Radiation | Erlotinib + Docetaxel |
Primary outcome
Maximum tolerated dose (MTD) of erlotinib and docetaxel during concomitant boost radiation
Time frame: 6 weeks of treatment, followed
MTD defined as highest dose level in which 6 patients have been treated with less than or equal to 2 instances of Dose-limiting toxicity (DLT) from 2 sources: 1) Out-of-field toxicity from unirradiated sites secondary to systemic therapy(erlotinib and docetaxel); 2) In-field toxicity from irradiated sites secondary to combined treatment.
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 27 Feb 2012.
- UT MD Anderson 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.
Bonnie S. Glisson, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erlotinib, Docetaxel and Radiation Therapy in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center 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 11 inclusion and 12 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 27 Feb 2012. 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 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.
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?
Maximum tolerated dose (MTD) of erlotinib and docetaxel during concomitant boost radiation (time frame: 6 weeks of treatment, followed). 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 27 Feb 2012.