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Anti-cancer agent

Chemotherapy + Erlotinib for Head and Neck Cancer

Phase 2

Recruiting

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

ECOG PS ≤ 2 (Appendix C)

Age ≥ 18 years.

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days after third cycle of treatment

Summary

This trial is studying if adding erlotinib to standard chemotherapy can help control SCCHN and to see if it is safe.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include reactions related to infusion, fatigue, digestive problems like nausea and diarrhea from chemotherapy; Erlotinib might cause rashes and breathing difficulties.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and perform daily activities.

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I am 18 years old or older.

Exclusion Criteria

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

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I am allergic to certain chemotherapy drugs or their ingredients.

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I am not on any cancer treatment except for hormone therapy for breast or prostate cancer.

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My cancer is not squamous cell carcinoma.

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I am not pregnant, breastfeeding, and I use effective birth control.

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My cancer did not start in my mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days after third cycle of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days after third cycle of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days after third cycle of treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Pathological Complete Response (pCR)

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531

29%

Nausea

19%

Leukopenia

14%

Anaemia

14%

Vomiting

14%

Neutropenia

14%

Alanine aminotransferase increased

14%

White blood cell count decreased

14%

Thrombocytopenia

10%

Neutrophil count decreased

10%

Platelet count decreased

10%

Aspartate aminotransferase increased

Musculoskeletal pain

Dizziness

Diarrhea

Back pain

100%

80%

60%

40%

20%

Study treatment Arm

Erlotinib-Chemotherapy

Chemotherapy-Erlotinib

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy

2003

Completed Phase 4

~3050

Phone Call

2016

Completed Phase 4

~20680