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Alkylating Agent

OSI-774 + Chemotherapy for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Xiuning Le, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Normal organ and marrow function

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

Must not have

Received prior biologic therapy targeting EGFR

Signs or symptoms of acute infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; and average of 1 year

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is studying if a new combination of drugs is effective in treating head and neck cancer. The safety of the treatment will also be looked at.

Who is the study for?

Adults with metastatic or recurrent head and neck squamous cell carcinoma who haven't had systemic chemotherapy for this condition. They must have measurable disease, be in a stable health condition, not pregnant, willing to use contraception, and without severe allergies to the drugs being tested.

What is being tested?

The trial is testing the effectiveness and safety of combining Tarceva (OSI-774) with Platinol (cisplatin) and Taxotere (docetaxel) in treating advanced head and neck cancer. It aims to see if this new drug combination can help patients.

What are the potential side effects?

Possible side effects include reactions related to infusion treatments, fatigue, digestive issues like nausea or diarrhea, blood-related problems such as low counts leading to increased infection risk, skin reactions, and potential organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My organs and bone marrow are functioning normally.

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I had cancer other than melanoma over 5 years ago and have been cancer-free since.

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I can take care of myself but might not be able to do heavy physical work.

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My cancer is a type of head and neck cancer that has spread or come back.

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I am currently not suffering from any sudden illnesses or infections.

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I am 18 years old or older.

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I have a tumor that can be measured and is at least as big as specified.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received treatment targeting EGFR before.

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I am currently being treated for an infection.

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I am on anti-retroviral therapy for an immune deficiency.

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I've had chemotherapy or radiotherapy for my recurring or spreading head and neck cancer.

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My cancer has spread to my brain.

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I need nutrition through an IV including fats.

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I have moderate to severe nerve damage.

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My cancer is not squamous cell carcinoma.

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I am unwilling to sign the informed consent.

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I do not have any uncontrolled illnesses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; and average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; and average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; and average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response Rate

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cisplatin + Docetaxel + OSI-774Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Erlotinib

FDA approved

Docetaxel

FDA approved

Cisplatin

FDA approved

0 / 17Eligibility criteria met