Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV
• Docetaxel — DRUG
  Given IV
• Erlotinib Hydrochloride — DRUG
  Given PO
• Laboratory Biomarker Analysis — OTHER
  Optional correlative studies
• Pharmacological Study — OTHER
  Optional correlative studies
• Placebo — OTHER
  Given PO
• Quality-of-Life Assessment — OTHER
  Ancillary studies

Study Details

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.

Key Dates

First listed

Feb 8, 2010

Start date

Feb 5, 2010

Status verified

Jul 2024

Primary completion

Nov 3, 2020

Completion

Nov 3, 2020

Study Design

Enrollment

123 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (combination chemotherapy and erlotinib hydrochloride)
  Patients receive docetaxel IV over 1 hour and cisplatin IV over 2 hours or carboplatin IV over 2 hours on day 1 and erlotinib hydrochloride PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue erlotinib hydrochloride treatment.
• Active Comparator: Arm B (combination chemotherapy and placebo)
  Patients receive docetaxel and cisplatin or carboplatin as in Arm I and placebo PO daily on days 1-21. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression and unacceptable toxicity. Patients achieving complete response, partial response, or stable disease may continue placebo treatment.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: 5 years ]

Locations (5)

Find similar trials in Houston, TX

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