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Compensation: Varies

Number of Visits: 3

Duration: 9 weeks

55 Participants Needed

Chemotherapy + Erlotinib for Head and Neck Cancer

Overseen ByXiuning Le, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Anticancer therapy

Disqualifiers: Non-squamous histology, Other sites, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Research Team

Xiuning Le, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults over 18 with a specific type of throat cancer (SCCHN) that can be surgically removed may join this study. They must have normal organ function and blood counts, not be on other cancer treatments, and agree to use birth control if they can have children. People with serious health issues, different cancers within the last two years, or allergies to similar drugs cannot participate.

Inclusion Criteria

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;

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Exclusion Criteria

I have had treatments for a different head and neck cancer before, but not for my current one.

I don't have severe gut issues that could affect medication absorption, but I may use a feeding tube.

Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive docetaxel and either cisplatin or carboplatin by vein on Day 1 of up to 3 study cycles, and take tablets of either erlotinib or placebo daily until the day before surgery.

9 weeks

3 visits (in-person) for chemotherapy administration

Surgery

Participants undergo surgery after completing the treatment phase.

End of Treatment Visit

About 8 weeks after surgery, participants undergo a physical exam, blood tests, and complete a questionnaire.

8 weeks post-surgery

Long Term Follow-up

Participants are contacted at least once a year to check on their status.

Treatment Details

Interventions

Docetaxel
Erlotinib

Trial Overview The trial is testing whether adding Erlotinib to standard chemo (Docetaxel plus Cisplatin or Carboplatin) before surgery helps treat throat cancer better than chemo alone. Some patients will get Erlotinib while others will get a placebo (a fake drug), chosen randomly.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Chemotherapy + PlaceboExperimental Treatment5 Interventions

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.

Group II: Chemotherapy + ErlotinibExperimental Treatment5 Interventions

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.

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications: