Head and Neck CancerPhase 2NCT01927744
Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection
A Phase 2 study testing Docetaxel, Erlotinib and Questionnaires 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 learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied. In this study, erlotinib will be compared to a placebo. 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?
- Docetaxel, Erlotinib and Questionnaires
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2013to 6 Jan 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Suspected or histologically/citologically confirmed HNSCC of the oral cavity, stage III, IVA or IVB (according to the AJCC 7th edition). Patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study. If squamous cell histology is not confirmed, patients will be discontinued from the study.
- Patients must have surgically resectable disease, in the opinion of the treating physician
- Age ≥ 18 years.
- ECOG PS ≤ 2 (Appendix C)
- Adequate bone marrow, hepatic and renal function defined by: 6. ANC ≥ 1.5 x 109/L;
- 7. Platelet count ≥ 100 x 109/L;
Show all 12Show fewer
- 8. ALT (SGPT) ≤ 1.5 x upper limit of normal (ULN);
- 9. Total bilirubin ≤ ULN (patient's with Gilbert's syndrome are eligible, even if total bilirubin is > ULN);
- 10. Alkaline phosphatase ≤ 2.5 x ULN;
- 11. Serum creatinine ≤ 1.5 x ULN.
- 12. Patients with reproductive potential (e.g., females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy. Female patients of childbearing potential must provide a negative pregnancy test (serum or urine) ≤ 14 days prior to treatment initiation.
- 13. Written informed consent to participate in the study according to the investigational review board (IRB).
Who cannot join
- Histology other than squamous cell carcinoma.
- Primary sites other than oral cavity.
- Prior chemotherapy or biologic therapy for the same HNSCC. Prior chemotherapy or biologic therapy for a different previous HNSCC is allowed
- History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g., Crohn's disease, ulcerative colitis). Patients requiring feeding tubes are permitted
- Other active solid malignancies within 2 years prior to randomization, except for basal cell or squamous cell skin cancer or in situ cervical or breast cancer or superficial melanoma.
- Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician.
Show all 9Show fewer
- History of allergic reactions to compounds of similar chemical composition to the study drugs (docetaxel, cisplatin, carboplatin, erlotinib or their excipients), or other drugs formulated with polysorbate 80.
- Any concurrent anticancer therapy, excluding hormonal therapy for prostate or breast cancer.
- Women who are pregnant or breast-feeding and women or men not practicing effective birth control.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Randomized, Placebo-Controlled, Phase 2 Study Of Induction Chemotherapy With Cisplatin/Carboplatin, And Docetaxel With Or Without Erlotinib In Patients With Head And Neck Squamous Cell Carcinomas Amenable For Surgical Resection
The goal of this clinical research study is to learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied.
In this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Read more
This is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin, and carboplatin are all FDA approved and commercially available for the treatment of SCCHN.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups (also known as an Arm):
- If you are in Arm A, you will receive standard chemotherapy in combination with erlotinib.
- If you are in Arm B, you will receive standard chemotherapy in combination with a placebo.
If you are 1 of the first 30 patients to be enrolled on the study, you will have an equal chance of being assigned to either group. If you are one of the next 20 patients to be enrolled on the study, you will have a higher chance of being assigned to the group that appears to be performing better. Up to 50 more participants will then be assigned to a study group based on the results seen in the first 50 participants.
Neither you nor the study doctor will know if you are receiving erlotinib or placebo. However, if needed for your safety, the study doctor will be able to find out what you are receiving.
Study Drug Administration:
You will receive docetaxel and either cisplatin or carboplatin by vein on Day 1 of up to 3 study cycles, over about 1-2 hours. The study doctor will tell you whether you are receiving cisplatin or carboplatin. Each study cycle will be 3 weeks.
You will also take tablets of either erlotinib or placebo every day until (and including) the day before your scheduled surgery. You should take the tablets with about 1 cup (8 ounces) of water. You should take the tablet on an empty stomach, at least 1 hour before or 2 hours after a meal. You should take the tablet at around the same time each day, preferably in the morning. Your eating habits around the time you take the tablet should stay the same while you are on study. lf you vomit, and you can actually see the tablet, you may take another tablet. If not, you should not take another tablet until your next scheduled dose.
You will continue to take erlotinib or placebo daily until the day prior to surgery (including the day prior to surgery).
You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
Study Visits:
On Day 1 of each Cycle, you will receive the study drugs, as described above.
Within 7 days before Cycles 2 and 3:
- You will have a physical exam.
- You will be asked about your current smoking status and tobacco use.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
At least 14 days after the last dose of chemotherapy:
- You will have a physical exam.
- You will be asked about your current smoking status and tobacco use.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
- You will have an MRI or CT scan of the head and neck. If the study doctor thinks it is needed, additional imaging scans may be performed.
- You will complete a questionnaire about how you feel about different aspects of your daily life. It should take you about 15 minutes to complete the questionnaire.
- Blood (about 1-2 teaspoons) will be drawn for biomarker and pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points.
At any point while you are on study, if you can become pregnant and your doctor thinks it is needed, you will have a blood (about 1 teaspoon) or urine pregnancy test.
Surgery:
After you stop taking the study drug/placebo, you will have the surgery you were already scheduled to receive. You will sign a separate consent form that describes the surgery and its risks. As part of this study, tumor tissue will be collected during the surgery and checked for the status of the disease as well as any spread of the disease.
Length of Study:
You may receive the standard chemotherapy combination for up to 3 cycles. You may take the study drug/placebo up until the day before surgery. If you have side effects from the chemotherapy, it is possible that you may stop taking the chemotherapy combination and continue to receive the study drug/placebo up until surgery. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your active participation on the study will be over after the end-of-treatment visit.
End of Treatment Visit:
About 8 weeks after surgery, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 1-2 teaspoons) will be drawn for biomarker and PK testing.
- You will complete the questionnaire about your daily life.
- If you can become pregnant and your doctor thinks it is needed, you will have a blood (about 1 teaspoon) or urine pregnancy test.
Long Term Follow Up:
After the end of treatment visit, you will be called at least 1 time each year to check on how you are doing. You (or your family members or designees) may be contacted by telephone, in writing, by e-mail, or during clinic visits. It is important to keep your contact information up to date with the study staff. This information may also be collected by checking your medical record.
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Squamous cell carcinoma of the head and neck, SCCHN, Oral cavity squamous cell carcinomas, Docetaxel, Taxotere, Erlotinib, Erlotinib Hydrochloride, OSI-774, CP358774, Tarceva, Questionnaire, Survey, Phone call
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Also called Taxotere
75 mg/m2 by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
ErlotinibDrug
Also called Erlotinib Hydrochloride, OSI-774, CP358774, Tarceva
150 mg by mouth daily continuously until the day before surgery.
PlaceboOther
150 mg by mouth daily continuously until the day before surgery.
QuestionnairesBehavioural
Also called Surveys
Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery.
Phone CallBehavioural
Phone call made to patient 1 time each year after the end of treatment visit.
ChemotherapyDrug
Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + Erlotinib | Experimental | Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus Erlotinib 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit. Receives: Drug: Docetaxel; Drug: Erlotinib; Behavioral: Questionnaires; Behavioral: Phone Call; Drug: Chemotherapy |
| Chemotherapy + Placebo | Experimental | Docetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus placebo 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit. Receives: Drug: Docetaxel; Other: Placebo; Behavioral: Questionnaires; Behavioral: Phone Call; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathologic Response (MPR) Rate (Primary (Overall) Analysis)
Major Pathologic Response (MPR) was defined as ≤ 10% residual biable tumor cells in the resected primary tumor specimen following completion of neadjuvant therapy.
Measured: At surgery following completion of induction chemotherapy (up to approximately 63 days after treatment initiation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study start16 Dec 2013
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc, The Kadoorie Charitable Foundations
- Responsible party
- Sponsor
- Investigators
- Xiuning Le, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927744
- Sponsor's protocol ID
- 2013-0179
- Other IDs
- NCI-2014-01390
- Status last verified
- Oct 2025
- First submitted
- 20 Aug 2013
- Last updated
- 26 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-Controlled, Phase 2 Study Of Induction Chemotherapy With Cisplatin/Carboplatin, And Docetaxel With Or Without Erlotinib In Patients With Head And Neck Squamous Cell Carcinomas Amenable For Surgical Resection
- ClinicalTrials.gov ID
- NCT01927744
- Acronym / sponsor ID
- 2013-0179
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Squamous cell carcinoma of the head and neck, SCCHN, Oral cavity squamous cell carcinomas, Docetaxel, Taxotere, Erlotinib, Erlotinib Hydrochloride
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc, The Kadoorie Charitable Foundations
- Study start
- 16 Dec 2013 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Posted 26 Nov 2025
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 learn if adding erlotinib to a standard chemotherapy combination (docetaxel and either cisplatin or carboplatin) can help to control SCCHN. The safety of this drug combination will also be studied.
In this study, erlotinib will be compared to a placebo. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
This is an investigational study. Erlotinib is approved by the FDA for treatment of non-small cell lung cancer. Its use in this study is experimental. Docetaxel, cisplatin, and carboplatin are all FDA approved and commercially available for the treatment of SCCHN.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups (also known as an Arm):
- If you are in Arm A, you will receive standard chemotherapy in combination with erlotinib.
- If you are in Arm B, you will receive standard chemotherapy in combination with a placebo.
If you are 1 of the first 30 patients to be enrolled on the study, you will have an equal chance of being assigned to either group. If you are one of the next 20 patients to be enrolled on the study, you will have a higher chance of being assigned to the group that appears to be performing better. Up to 50 more participants will then be assigned to a study group based on the results seen in the first 50 participants.
Neither you nor the study doctor will know if you are receiving erlotinib or placebo. However, if needed for your safety, the study doctor will be able to find out what you are receiving.
Study Drug Administration:
You will receive docetaxel and either cisplatin or carboplatin by vein on Day 1 of up to 3 study cycles, over about 1-2 hours. The study doctor will tell you whether you are receiving cisplatin or carboplatin. Each study cycle will be 3 weeks.
You will also take tablets of either erlotinib or placebo every day until (and including) the day before your scheduled surgery. You should take the tablets with about 1 cup (8 ounces) of water. You should take the tablet on an empty stomach, at least 1 hour before or 2 hours after a meal. You should take the tablet at around the same time each day, preferably in the morning. Your eating habits around the time you take the tablet should stay the same while you are on study. lf you vomit, and you can actually see the tablet, you may take another tablet. If not, you should not take another tablet until your next scheduled dose.
You will continue to take erlotinib or placebo daily until the day prior to surgery (including the day prior to surgery).
You will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.
Study Visits:
On Day 1 of each Cycle, you will receive the study drugs, as described above.
Within 7 days before Cycles 2 and 3:
- You will have a physical exam.
- You will be asked about your current smoking status and tobacco use.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
At least 14 days after the last dose of chemotherapy:
- You will have a physical exam.
- You will be asked about your current smoking status and tobacco use.
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
- You will have an MRI or CT scan of the head and neck. If the study doctor thinks it is needed, additional imaging scans may be performed.
- You will complete a questionnaire about how you feel about different aspects of your daily life. It should take you about 15 minutes to complete the questionnaire.
- Blood (about 1-2 teaspoons) will be drawn for biomarker and pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points.
At any point while you are on study, if you can become pregnant and your doctor thinks it is needed, you will have a blood (about 1 teaspoon) or urine pregnancy test.
Surgery:
After you stop taking the study drug/placebo, you will have the surgery you were already scheduled to receive. You will sign a separate consent form that describes the surgery and its risks. As part of this study, tumor tissue will be collected during the surgery and checked for the status of the disease as well as any spread of the disease.
Length of Study:
You may receive the standard chemotherapy combination for up to 3 cycles. You may take the study drug/placebo up until the day before surgery. If you have side effects from the chemotherapy, it is possible that you may stop taking the chemotherapy combination and continue to receive the study drug/placebo up until surgery. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your active participation on the study will be over after the end-of-treatment visit.
End of Treatment Visit:
About 8 weeks after surgery, the following tests and procedures will be performed:
- You will have a physical exam.
- Blood (about 1-2 teaspoons) will be drawn for biomarker and PK testing.
- You will complete the questionnaire about your daily life.
- If you can become pregnant and your doctor thinks it is needed, you will have a blood (about 1 teaspoon) or urine pregnancy test.
Long Term Follow Up:
After the end of treatment visit, you will be called at least 1 time each year to check on how you are doing. You (or your family members or designees) may be contacted by telephone, in writing, by e-mail, or during clinic visits. It is important to keep your contact information up to date with the study staff. This information may also be collected by checking your medical record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + Erlotinib | Experimental | Drug: Docetaxel, Drug: Erlotinib, Behavioral: Questionnaires, Behavioral: Phone Call, Drug: ChemotherapyDocetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus Erlotinib 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit. |
| Chemotherapy + Placebo | Experimental | Drug: Docetaxel, Other: Placebo, Behavioral: Questionnaires, Behavioral: Phone Call, Drug: ChemotherapyDocetaxel 75 mg/m2 by vein followed by Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles, plus placebo 150 mg by mouth daily continuously until the day before surgery. Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. Phone call made to patient 1 time each year after the end of treatment visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Suspected or histologically/citologically confirmed HNSCC of the oral cavity, stage III, IVA or IVB (according to the AJCC 7th edition). Patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study. If squamous cell histology is not confirmed, patients will be discontinued from the study.
- Patients must have surgically resectable disease, in the opinion of the treating physician
- Age ≥ 18 years.
- ECOG PS ≤ 2 (Appendix C)
- Adequate bone marrow, hepatic and renal function defined by: 6. ANC ≥ 1.5 x 109/L;
Key exclusion criteria (9 listed)
- Histology other than squamous cell carcinoma.
- Primary sites other than oral cavity.
- Prior chemotherapy or biologic therapy for the same HNSCC. Prior chemotherapy or biologic therapy for a different previous HNSCC is allowed
- History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g., Crohn's disease, ulcerative colitis). Patients requiring feeding tubes are permitted
- Other active solid malignancies within 2 years prior to randomization, except for basal cell or squamous cell skin cancer or in situ cervical or breast cancer or superficial melanoma.
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 |
|---|---|---|
| DocetaxelAlso: Taxotere75 mg/m2 by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles. | Drug | Chemotherapy + Erlotinib, Chemotherapy + Placebo |
| ErlotinibAlso: Erlotinib Hydrochloride, OSI-774, CP358774, Tarceva150 mg by mouth daily continuously until the day before surgery. | Drug | Chemotherapy + Erlotinib |
| Placebo150 mg by mouth daily continuously until the day before surgery. | Other | Chemotherapy + Placebo |
| QuestionnairesAlso: SurveysQuestionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery. | Behavioural | Chemotherapy + Erlotinib, Chemotherapy + Placebo |
| Phone CallPhone call made to patient 1 time each year after the end of treatment visit. | Behavioural | Chemotherapy + Erlotinib, Chemotherapy + Placebo |
| ChemotherapyCisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles. | Drug | Chemotherapy + Erlotinib, Chemotherapy + Placebo |
Primary outcome
Major Pathologic Response (MPR) Rate (Primary (Overall) Analysis)
Time frame: At surgery following completion of induction chemotherapy (up to approximately 63 days after treatment initiation).
Major Pathologic Response (MPR) was defined as ≤ 10% residual biable tumor cells in the resected primary tumor specimen following completion of neadjuvant therapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Xiuning Le, 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 2 study testing Docetaxel, Erlotinib and Questionnaires 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 12 inclusion and 9 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 26 Nov 2025. 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 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?
Yes. Results are posted in the registry (first posted 26 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Major Pathologic Response (MPR) Rate (Primary (Overall) Analysis) (time frame: At surgery following completion of induction chemotherapy (up to approximately 63 days after treatment initiation).). 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 26 Nov 2025.