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Head and Neck CancerPhase 2NCT00076310

OSI-774/Cisplatin/Taxotere in Head & Neck Squamous Cell Cancer

A Phase 2 study testing Docetaxel, OSI-774 and Cisplatin in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. 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, OSI-774 and Cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
28 Jan 2004to 1 May 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

  • Have histologically or cytologically confirmed metastatic or recurrent head and neck squamous cell carcinoma from the primary lesion and/or lymph nodes of the oral cavity, oropharynx, hypopharynx, or larynx.
  • Have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan. See section 9.2 for the evaluation of measurable disease.
  • Have not received any prior systemic chemotherapy for metastatic or recurrent head and neck squamous cell carcinoma. If patients have received prior combined modality therapy, they must be off therapy for at least 6 months.
  • Be >= 18 years of age.
  • No acute intercurrent illness or infection.
  • ECOG performance status =<2 (Karnofsky =>60%). Have normal organ and marrow function defined as: leukocytes=>3,000/uL; absolute neutrophil count=>1,500/uL; platelets =>100,000/uL hemoglobin >= 8g/dl; total bilirubin within normal institutional limits; AST(SGOT)/ALT(SGPT) =<2.5 X institutional upper limit of normal if alkaline phosphate is <ULN OR alkaline phosphatase may be up to 4x ULN if transaminases are <ULN; creatinine =<2.0 xULN OR creatinine clearance >60 mL/min/1.73 m**2 for patients with creatinine levels above institutional normal
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  • The effects of OSI-774 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 3 months after the completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • History of non-melanoma skin cancer, or other malignancies treated 5 years or more prior to the current tumor, from which the patient has remained continually disease-free, are eligible.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Inclusion of women and minorities. Both men and women and members of all ethnic groups are eligible for this trial. The proposed study population will consist of patients of all ethnic backgrounds and either gender, treated at MD Anderson Cancer Center in Houston, Texas.

Who cannot join

  • Patients who have had chemotherapy or non-palliative radiotherapy for their recurrent or metastatic head and neck cancer.
  • Patients may not be receiving any other investigational agents.
  • Brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774 or other agents used in the study.
  • Patient has received prior biologic therapy targeting EGFR.
  • Signs or symptoms of acute infection requiring systemic therapy.
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  • Exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent.
  • Requires total parenteral nutrition with lipids.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Histology other than squamous cell carcinoma.
  • Refusing to sign the informed consent.
  • History of severe hypersensitivity reaction to Taxotere®.
  • Pre-existing peripheral neuropathy NCI CTC grade 2 or worse.
  • Pregnant or lactating women are excluded from this study because OSI-774 is an unknown Class agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774, breastfeeding should be discontinued if the mother is treated with OSI-774. These potential risks may also apply to other agents used in this study.
  • Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774, cisplatin, or docetaxel or other agents administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase II Study of OSI-774 in Combination With Cisplatin and Docetaxel in Metastatic or Recurrent Head and Neck Squamous Cell Cancer

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.

Read the detailed description

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.

Being tested
Docetaxel, OSI-774, Cisplatin
Keywords
Head and Neck Cancer, Squamous Cell Cancer, OSI-774, Cisplatin, Platinol®-AQ, Platinol®, CDDP, Docetaxel, Taxotere, Tarceva, HNSCC, Erlotinib Hydrochloride
Medical subject headings
Head and Neck Neoplasms, Neoplasms, Squamous Cell, 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

    60 mg/m^2 IV repeated every 21 days.

  • OSI-774Drug

    Also called Tarceva, Erlotinib Hydrochloride

    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.

  • CisplatinDrug

    Also called Platinol®-AQ, Platinol®, CDDP

    75 mg/m^2 IV every 21 days.

Study groups in NCT00076310
Study groupRoleWhat they receive
Cisplatin + Docetaxel + OSI-774ExperimentalCisplatin 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.
Receives: Drug: Docetaxel; Drug: OSI-774; Drug: Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: after 2 cycles of treatment (6 weeks) and confirmed 4-6 weeks thereafter

Secondary outcomes (2)

  1. 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.

    Measured: From treatment initiation until 150 months after initiation of treatment

  2. 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

    Measured: time of first drug administration to 30 days after last drug administration (maximum of 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2004 (estimated)
  2. Study start28 Jan 2004
  3. Primary completion1 May 2025
  4. Study completion1 May 2025

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00076310
Sponsor's protocol ID
ID02-668
Status last verified
Jul 2026
First submitted
20 Jan 2004
Last updated
22 Jul 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • William WN Jr, Tsao AS, Feng L, Ginsberg LE, Lee JJ, Kies MS, Glisson BS, Kim ES. Single Arm, Phase II Study of Cisplatin, Docetaxel, and Erlotinib in Patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas. Oncologist. 2018 May;23(5):526-e49. doi: 10.1634/theoncologist.2017-0661. Epub 2018 Jan 25.

    PubMed 29371473

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, OSI-774 and Cisplatin 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 10 inclusion and 15 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 22 Jul 2026. 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 15 Apr 2026). 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?

Overall Response Assessment (Radiographic RECIST) (time frame: after 2 cycles of treatment (6 weeks) and confirmed 4-6 weeks thereafter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00076310, which also lists 1 linked publication.

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 22 Jul 2026.

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