A Phase 2 interventional study of Docetaxel and OSI-774 in Head and Neck Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment
The goal of this clinical research study is to learn if giving the new drug, Tarceva® (OSI-774), in combination with Platinol® (cisplatin) and Taxotere® (docetaxel) is effective in the treatment of metastatic or recurrent head and neck cancer. The safety of this treatment will also be studied.
OSI-774 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 these enzymes will slow tumor growth. Both cisplatin and docetaxel are commonly used chemotherapy drugs. These drugs are designed to target and destroy cancer cells.
Before the study, you will have a physical exam, blood tests (around 2 teaspoons), and an electrocardiogram (ECG - a test that measures the electrical activity of the heart). You will also have a chest x-ray and a CT scan. If the diagnosis has not yet been confirmed, a biopsy of the tumor may need to be done. Women who are able to have children must have a negative blood or urine pregnancy test.
During treatment, you will take OSI-774 by mouth once a day. Once every 3 weeks, you will be given docetaxel and cisplatin. Docetaxel is given by a continuous infusion into a vein over 1 hour. This will be followed by an infusion into a vein of cisplatin over 2 hours. Treatment with docetaxel and cisplatin is given every 3 weeks for 18 weeks. You will continue to take OSI-774 until your disease worsens, until side effects become too severe, or until your doctor thinks it is no longer benefiting you.
If at any time during the study the disease becomes worse or you experience any intolerable side effects, you will be taken off the study and your doctor will discuss other treatment options with you.
During the study, you will have blood drawn (around 2 teaspoons) once a week. These samples will be used for routine lab tests. Every 3 weeks, you will have a physical exam and your vital signs and weight will be measured. You will also be asked about any side effects you may be experiencing. If your doctor feels it is necessary, you may have more frequent check-up visits.
Every 6 weeks during treatment, you will have blood tests (around 2 teaspoons), and imaging tests. The imaging tests include a chest x-ray and a CT scan of the head and neck area. You may also have CT scans of other areas of the body. These tests are being done to check on the status of the disease.
You may continue receiving OSI-774 for as long as your cancer responds to study treatment. If you continue to receive OSI-774, every 3 months you will have a physical exam (including measurement of vital signs), routine blood tests (about 2 teaspoons), a performance status test (a test looking at the ability to perform everyday activities), a chest x-ray, and a CT or MRI scan. Your doctor may decide to take you off this study if you experience significant side effects or your medical condition worsens.
This is an investigational study. OSI-774 is approved by the FDA for treatment of NSCLC in patients who have relapsed. Its use in this study is considered investigational. Docetaxel and cisplatin are FDA approved and commercially available. There will be a total of 50 patients taking part in this study. There will be no cost for OSI-774 or for any tests and procedures performed solely for this research study.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's enrollment of 50 is close to the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.
Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cisplatin 75 mg/m\^2 IV every 21 days. Docetaxel 60 mg/m\^2 IV repeated every 21 days. OSI-774 100 mg oral administered daily. May have a dose escalation of 150 mg pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached.
Drug: Docetaxel · Drug: OSI-774 · Drug: Cisplatin
60 mg/m\^2 IV repeated every 21 days.
Also known as: Taxotere
100 mg oral administered daily. May have a dose escalation of 150 mg pending on prior dose toleration. Patients will continue on daily OSI-774 until a study endpoint or removal from study is reached.
Also known as: Tarceva, Erlotinib Hydrochloride
75 mg/m\^2 IV every 21 days.
Also known as: Platinol®-AQ, Platinol®, CDDP
Overall Response Assessment (Radiographic RECIST)
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter from the smallest sum diameter recorded, NE = not evaluable
Time frame: after 2 cycles of treatment (6 weeks) and confirmed 4-6 weeks thereafter
Progression Free Survival and Overall Survival Duration Assessments
Analyses of overall survival (OS) and progression-free survival (PFS) were performed. OS was defined as from treatment initiation to death or last follow-up time. PFS was defined as from treatment initiation to progression or death, whichever occurred first, or last follow-up. The distribution was estimated by Kaplan-Meier method.
Time frame: From treatment initiation until 150 months after initiation of treatment
Toxicity -- Number of Adverse Events
Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines. All AEs, whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy
Time frame: time of first drug administration to 30 days after last drug administration (maximum of 6 months)
| Milestone | Experimental (OSI-774 Erlotinib) |
|---|---|
| Started | 50 |
| Completed | 33 |
| Not completed | 17 |
| Withdrew: Adverse event | 9 |
| Withdrew: Death | 7 |
| Withdrew: Patient withdrawal | 1 |
Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter from the smallest sum diameter recorded, NE = not evaluable
| Participants | Experimental (OSI-774 Erlotinib) |
|---|---|
| RECIST Response Assessment: CR | 4 |
| RECIST Response Assessment: PR | 27 |
| RECIST Response Assessment: SD | 13 |
| RECIST Response Assessment: PD | 3 |
| RECIST Response Assessment: NE | 3 |
Analyses of overall survival (OS) and progression-free survival (PFS) were performed. OS was defined as from treatment initiation to death or last follow-up time. PFS was defined as from treatment initiation to progression or death, whichever occurred first, or last follow-up. The distribution was estimated by Kaplan-Meier method.
| Months | Experimental (OSI-774 Erlotinib) |
|---|---|
| PFS | 6.11 (5.32 to 7.59) |
| OS | 11 (8.28 to 14.9) |
Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 4.0 guidelines. All AEs, whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy
| adverse events | Experimental (OSI-774 Erlotinib) |
|---|---|
| Grade 4, Definite | 0 |
| Grade 4, Probable | 1 |
| Grade 4, Possible | 26 |
| Grade 4, Unlikely | 3 |
| Grade 4, Unrelated | 2 |
| Grade 3, Definite | 0 |
| Grade 3, Probable | 4 |
| Grade 3, Possible | 50 |
| Grade 3, Unlikely | 1 |
| Grade 3, Unrelated | 2 |
| Grade 2, Definite | 0 |
| Grade 2, Probable | 1 |
| Grade 2, Possible | 62 |
| Grade 2, Unlikely | 1 |
| Grade 2, Unrelated | 26 |
| Grade 1, Definite | 0 |
| Grade 1, Probable | 0 |
| Grade 1, Possible | 372 |
| Grade 1, Unlikely | 7 |
| Grade 1, Unrelated | 467 |
Collected over Adverse Events were assessed from time of first drug administration to 30 days after last drug administration, maximum of 6 months. All-cause mortality was assessed from treatment initiation until 150 months after initation of treatment. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental (OSI-774 Erlotinib) | 48/50 (96%) | 29/50 (58%) | 50/50 (100%) |
| Event | Experimental (OSI-774 Erlotinib) |
|---|---|
| DehydrationMetabolism and nutrition disorders | 9/50 |
| DeathGeneral disorders | 7/50 |
| DiarrheaGastrointestinal disorders | 5/50 |
| InfectionInfections and infestations | 5/50 |
| Febrile neutropeniaBlood and lymphatic system disorders | 4/50 |
| HypotensionVascular disorders | 4/50 |
| NeutropeniaInvestigations | 4/50 |
| HemoglobinBlood and lymphatic system disorders | 3/50 |
| NauseaGastrointestinal disorders | 3/50 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 3/50 |
| Event | Experimental (OSI-774 Erlotinib) |
|---|---|
| FatigueGeneral disorders | 41/50 |
| LymphopeniaBlood and lymphatic system disorders | 35/50 |
| NauseaGastrointestinal disorders | 33/50 |
| Rash/desquamationSkin and subcutaneous tissue disorders | 31/50 |
| DiarrheaGastrointestinal disorders | 30/50 |
| DysphagiaGastrointestinal disorders | 29/50 |
| AnemiaBlood and lymphatic system disorders | 26/50 |
| TrismusMusculoskeletal and connective tissue disorders | 20/50 |
| InsomniaGeneral disorders | 19/50 |
| ConstipationGastrointestinal disorders | 18/50 |
| Age, Categorical(Participants) | Experimental (OSI-774 Erlotinib) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 43 |
| >=65 years | 7 |
| Age, Continuous(years) | Experimental (OSI-774 Erlotinib) |
|---|---|
| Median | 57 (39 to 72) |
| Sex: Female, Male(Participants) | Experimental (OSI-774 Erlotinib) |
|---|---|
| Female | 8 |
| Male | 42 |
| Ethnicity (NIH/OMB)(Participants) | Experimental (OSI-774 Erlotinib) |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 49 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Experimental (OSI-774 Erlotinib) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 48 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Experimental (OSI-774 Erlotinib) |
|---|---|
| United States | 50 |
| Distribution of categorical clinical characteristics among evaluable patients(Participants) | Experimental (OSI-774 Erlotinib) |
|---|---|
| Performance Status 0 | 7 |
| Performance Status 1 | 41 |
| Performance Status 2 | 2 |
| Primary Site: Oropharynx | 19 |
| Primary Site: Oral Cavity | 15 |
| Primary Site: Larynx | 11 |
| Primary Site: Hypopharynx | 3 |
| Primary Site: Unknown | 2 |
| Disease Status at Entry: Locoregional Recurrence | 31 |
| Disease Status at Entry: Metastatic Disease | 19 |
| Smoking Status: Current | 13 |
| Smoking Status: Former | 25 |
| Smoking Status: Never | 12 |
| Prior Treatment: Radiotherapy alone | 4 |
| Prior Treatment: Surgery + Radiotherapy | 20 |
| Prior Treatment: Chemotherapy + Radiotherapy | 5 |
| Prior Treatment: Chemotherapy + Radiotherapy + Surgery | 14 |
| Prior Treatment: Untreated | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Erlotinib