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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborators: Astellas Pharma Inc; Kadoorie Foundation; OSI Pharmaceuticals; The Kadoorie Charitable Foundations
• Treatments: Carboplatin; Cisplatin; Docetaxel; Erlotinib Hydrochloride

Criteria

Inclusion Criteria:

1. Suspected or histologically/cytologically confirmed HNSCC of the oral cavity, stage III, IVA or IVB (according to the American Joint Committee on Cancer (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.

2. Patients must have surgically resectable disease, in the opinion of the treating physician

3. Age >/= 18 years

4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

5. Adequate bone marrow, hepatic and renal function defined by: a.) ANC >/= 1.5 x 10^9/L; b.) Platelet count >/= 100 x 10^9/L; c.) ALT (SGPT)(ULN); d.) Total bilirubineven if total bilirubin is > ULN); e.) Alkaline phosphatasecreatinine

6. Patients with reproductive potential (for example, 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)

7. Written informed consent to participate in the study according to the investigational review board (IRB).

Exclusion Criteria:

1. Histology other than squamous cell carcinoma.

2. Primary sites other than oral cavity.

3. Prior chemotherapy or biologic therapy for the same HNSCC. Prior chemotherapy or biologic therapy for a different previous HNSCC is allowed

4. History of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (for example, Crohn's disease, ulcerative colitis). Patients requiring feeding tubes are permitted

5. 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.

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

7. 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.

8. Any concurrent anticancer therapy, excluding hormonal therapy for prostate or breast cancer.

9. Women who are pregnant or breast-feeding and women or men not practicing effective birth control.