Study of Chemotherapy With Cisplatin/Carboplatin, and Docetaxel With or Without Erlotinib in Patients With Head and Neck Squamous Cell Carcinomas Amenable for Surgical Resection

NCT01927744 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2013-0179NCI-2014-01390
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Squamous cell carcinoma of the head and neck; SCCHN; Oral cavity squamous cell carcinomas; Docetaxel; Taxotere; Erlotinib; Erlotinib Hydrochloride; OSI-774; CP358774; Tarceva; Questionnaire; Survey; Phone call

Outcome Measures

Primary Outcomes (1)

• Major Pathologic Response (MPR) Rate (Primary (Overall) Analysis)

  Major Pathologic Response (MPR) was defined as ≤ 10% residual biable tumor cells in the resected primary tumor specimen following completion of neadjuvant therapy.

  At surgery following completion of induction chemotherapy (up to approximately 63 days after treatment initiation).

Study Arms (2)

Chemotherapy + Erlotinib

EXPERIMENTAL

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.

Drug: Docetaxel; Drug: Erlotinib; Behavioral: Questionnaires; Behavioral: Phone Call; Drug: Chemotherapy

Chemotherapy + Placebo

EXPERIMENTAL

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.

Drug: Docetaxel; Other: Placebo; Behavioral: Questionnaires; Behavioral: Phone Call; Drug: Chemotherapy

Interventions

Docetaxel DRUG

75 mg/m2 by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.

Also known as: Taxotere

Chemotherapy + Erlotinib; Chemotherapy + Placebo

Erlotinib DRUG

150 mg by mouth daily continuously until the day before surgery.

Also known as: Erlotinib Hydrochloride, OSI-774, CP358774, Tarceva

Chemotherapy + Erlotinib

Placebo OTHER

150 mg by mouth daily continuously until the day before surgery.

Chemotherapy + Placebo

Questionnaires BEHAVIORAL

Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery.

Also known as: Surveys

Chemotherapy + Erlotinib; Chemotherapy + Placebo

Phone Call BEHAVIORAL

Phone call made to patient 1 time each year after the end of treatment visit.

Chemotherapy + Erlotinib; Chemotherapy + Placebo

Chemotherapy DRUG

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.

Chemotherapy + Erlotinib; Chemotherapy + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected or histologically/citologically confirmed HNSCC of the oral cavity, stage III, IVA or IVB (according to the AJCC 7th edition). Patients with a suspected lesion may be enrolled and a baseline biopsy will be obtained as part of the study. If squamous cell histology is not confirmed, patients will be discontinued from the study.
• Patients must have surgically resectable disease, in the opinion of the treating physician
• Age ≥ 18 years.
• ECOG PS ≤ 2 (Appendix C)
• Adequate bone marrow, hepatic and renal function defined by: 6. ANC ≥ 1.5 x 109/L;
• \. Platelet count ≥ 100 x 109/L;
• \. ALT (SGPT) ≤ 1.5 x upper limit of normal (ULN);
• \. Total bilirubin ≤ ULN (patient's with Gilbert's syndrome are eligible, even if total bilirubin is \> ULN);
• \. Alkaline phosphatase ≤ 2.5 x ULN;
• \. Serum creatinine ≤ 1.5 x ULN.
• \. Patients with reproductive potential (e.g., females menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures for the duration of study drug therapy and for at least 30 days after completion of study drug therapy. Female patients of childbearing potential must provide a negative pregnancy test (serum or urine) ≤ 14 days prior to treatment initiation.
• \. Written informed consent to participate in the study according to the investigational review board (IRB).

You may not qualify if:

• Histology other than squamous cell carcinoma.
• Primary sites other than oral cavity.
• Prior chemotherapy or biologic therapy for the same HNSCC. Prior chemotherapy or biologic therapy for a different previous HNSCC is allowed
• History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g., Crohn's disease, ulcerative colitis). Patients requiring feeding tubes are permitted
• Other active solid malignancies within 2 years prior to randomization, except for basal cell or squamous cell skin cancer or in situ cervical or breast cancer or superficial melanoma.
• Serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, in the opinion of the treating physician.
• 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.
• Women who are pregnant or breast-feeding and women or men not practicing effective birth control.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Astellas Pharma Inc: collaborator
• The Kadoorie Charitable Foundations: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Docetaxel; Erlotinib Hydrochloride; Surveys and Questionnaires; Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Therapeutics

Results Point of Contact

• Title: Xiuning Le, MD
• Organization: M.D. Anderson Cancer Center

xle1@mdanderson.org

713-792-6363

Study Officials

• Xiuning Le, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 23, 2013
• Study Start: December 16, 2013
• Primary Completion: January 6, 2025
• Study Completion: January 6, 2025
• Last Updated: November 26, 2025
• Results First Posted: November 26, 2025

Record last verified: 2025-10

Locations

US (1)