Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
NCT01064479 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123
Last updated 2024-07-16
Summary
This randomized phase II trial studies how well combination chemotherapy with or without erlotinib hydrochloride works in treating patients with squamous cell carcinoma of the head and neck that has spread to other parts of the body or has come back. Drugs used in chemotherapy, such as docetaxel, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without erlotinib hydrochloride may be an effective treatment for squamous cell carcinoma of the head and neck.
Conditions
- Metastatic Squamous Cell Carcinoma of the Hypopharynx
- Metastatic Squamous Cell Carcinoma of the Larynx
- Metastatic Squamous Cell Carcinoma of the Oral Cavity
- Metastatic Squamous Cell Carcinoma of the Oropharynx
- Recurrent Hypopharyngeal Squamous Cell Carcinoma
- Recurrent Laryngeal Squamous Cell Carcinoma
- Recurrent Oral Cavity Squamous Cell Carcinoma
- Recurrent Oropharyngeal Squamous Cell Carcinoma
- Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IV Laryngeal Squamous Cell Carcinoma AJCC v7
- Stage IV Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IV Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7
- Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7
- Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVC Hypopharyngeal Squamous Cell Carcinoma AJCC v7
- Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7
- Stage IVC Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
- Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7
Interventions
- DRUG
-
Given IV
- DRUG
-
Given IV
- DRUG
-
Given IV
- DRUG
-
Erlotinib Hydrochloride
Given PO
- OTHER
-
Laboratory Biomarker Analysis
Optional correlative studies
- OTHER
-
Pharmacological Study
Optional correlative studies
- OTHER
-
Placebo
Given PO
- OTHER
-
Quality-of-Life Assessment
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Xiuning Le · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-02-05
- Primary Completion
- 2020-11-03
- Completion
- 2020-11-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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