Chemotherapy + Erlotinib for Head and Neck Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether adding erlotinib, a drug typically used for lung cancer, to standard chemotherapy (including docetaxel) can better control head and neck cancer. The study compares the effects of erlotinib with a placebo to determine if the drug combination is more effective. Ideal candidates for this trial have resectable squamous cell carcinoma of the oral cavity (a type of cancer in the mouth) at stage III, IVA, or IVB. Participants should not have received prior chemotherapy for this cancer.
As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on any other anticancer therapy while participating in this study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the combination of erlotinib and docetaxel is generally well-tolerated by patients. Previous studies found this combination effective in treating cancer, though it may cause some side effects. Common side effects include skin rash and diarrhea, which can be managed with proper care.
Erlotinib has FDA approval for treating non-small cell lung cancer, indicating its safety is well understood. Reports suggest that using it with chemotherapy drugs like docetaxel, cisplatin, or carboplatin can lead to better outcomes, although side effects may still occur.
Overall, this combination has shown promise in earlier research and is considered safe enough for further testing in clinical trials. However, like any treatment, risks exist, so discussing these with the trial team is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of chemotherapy and Erlotinib for head and neck cancer because Erlotinib offers a novel approach by targeting the epidermal growth factor receptor (EGFR), which plays a critical role in cancer cell growth. Unlike traditional chemotherapy that broadly attacks rapidly dividing cells, Erlotinib specifically interferes with cancer cell communication, potentially reducing tumor growth more effectively. Additionally, the oral administration of Erlotinib provides a more convenient option for patients compared to intravenous chemotherapy, potentially improving patient compliance and quality of life.
What evidence suggests that adding erlotinib to chemotherapy could be effective for head and neck cancer?
Research has shown that combining erlotinib with chemotherapy drugs like docetaxel might effectively treat head and neck cancer. In earlier studies, patients who took erlotinib had a 69.5% chance of remaining cancer-free for three years, with 81% still alive after this period. Erlotinib blocks signals that cancer cells need to grow, potentially enhancing the effects of chemotherapy. In this trial, one group of participants will receive the combination of chemotherapy and erlotinib to test its effectiveness in controlling the spread of head and neck cancer compared to another group receiving chemotherapy with a placebo.34678
Who Is on the Research Team?
Xiuning Le, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
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.
Long Term Follow-up
Participants are contacted at least once a year to check on their status.
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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:
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
- Breast Cancer
- Non-small Cell Lung Cancer
- Gastric Cancer
- Head and Neck Cancer
- Prostate Cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Astellas Pharma Inc
Industry Sponsor
Tadaaki Taniguchi
Astellas Pharma Inc
Chief Medical Officer since 2023
MD, PhD
Naoki Okamura
Astellas Pharma Inc
Chief Executive Officer since 2023
University of Tokyo, Faculty of Pharmacy
The Kadoorie Charitable Foundations
Collaborator
Citations
Erlotinib Plus Docetaxel in Treating Patients With Locally ...
Phase I/II trial to study the effectiveness of combining erlotinib with docetaxel in treating patients who have locally advanced, recurrent, ...
Final results of a phase II study of erlotinib, docetaxel and ...
Erlotinib, an EGFR tyrosine kinase inhibitor, had a 4.3% response rate as single agent in HNSCC. Because of the possible synergy and efficacy, ...
Phase II study of erlotinib and docetaxel with concurrent ...
Results: With a median follow-up of 48.7 months, the 3-year DFS, OS, locoregional failure-free survival, and distant metastasis-free survival was 69.5%, 81%, ...
A Randomized Phase III Trial of Second-line Erlotinib ...
Single-agent PEM showed an RR of 8.9% to 23% and a median overall survival (OS) rate ranging between 5.7 and 10 months. DOC and PEM resulted in clinically ...
Study Results | Erlotinib, Docetaxel, and Radiation Therapy ...
Head and Neck Cancer. Head and Neck Cancer. Intervention/Treatment. Drug ... Outcomes data from 6 participants who received the same treatment on CWRU1301 ...
Phase II Study of Erlotinib and Docetaxel with Concurrent ...
With a median follow-up of 48.7 months, the 3 year DFS, OS, locoregional failure free survival and distant metastasis free survival was 69.5%, 81%, 82.4%, and ...
Safety and efficacy of single‐agent docetaxel (Taxotere) ...
Of 274 patients analyzed, one patient achieved a complete response and 42 partial responses; thus, the overall response rate was 15.7%. The OS rate at baseline ...
Erlotinib Linked to Improved Survival in HNSCC
Results showed that adding erlotinib to cisplatin and docetaxel was superior to chemotherapy alone for both overall survival and progression- ...
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