Combination Chemotherapy With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Condition: 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
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Recurrence
Intervention: Carboplatin; Cisplatin; Docetaxel; Erlotinib Hydrochloride; Laboratory Biomarker Analysis; Pharmacological Study; Placebo; Quality-of-Life Assessment
Intervention description: Given IV; Given IV; Given IV; Given PO; Optional correlative studies; Optional correlative studies; Given PO; Ancillary studies
Intervention MeSH terms: Cisplatin; Carboplatin; Docetaxel; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed metastatic or recurrent squamous cell carcinoma of the head
             and neck (SCCHN) of the oral cavity, oropharynx, hypopharynx or larynx; metastatic or
             recurrent lesions of the nasopharynx and sinus are excluded

          -  Radiologically measurable disease, defined as at least one lesion that can be
             accurately measured in at least one dimension (longest diameter to be recorded) as >=
             20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT)
             scan; measurable lymph nodes are required to be >= 15 mm in size (short axis diameter)

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) =< 2

          -  Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

          -  Platelet count >= 100 x 10^9/L

          -  Total bilirubin =< upper limit of normal (ULN) (excluding Gilbert's disease)

          -  Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 1.5 x
             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) or independent ethics committee (IEC)

        Exclusion Criteria:

          -  Histology other than squamous cell carcinoma

          -  Primary sites other than oral cavity, oropharynx, hypopharynx, and larynx

          -  Prior palliative chemotherapy for metastatic or recurrent disease

          -  Prior biological therapy for metastatic or recurrent disease within 3 weeks prior to
             randomization

          -  Patients with known, untreated brain metastases; patients with treated (irradiated or
             resected) brain metastases are eligible if treatment was completed more than 28 days
             prior to study entry and if clinical neurologic function is stable

          -  Pre-existing peripheral neuropathy >= grade 2

          -  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 malignancies requiring chemotherapy treatment within 2 years prior to
             randomization, except for adequately treated basal cell or squamous cell skin cancer
             or in situ cervical or breast cancer or superficial, resected 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 anti-cancer therapy, excluding hormonal therapy for prostate or breast
             cancer

          -  Dementia or significantly altered mental status that would prohibit the understanding
             and giving of informed consent

          -  Women who are pregnant or breast-feeding and women or men not practicing effective
             birth control