Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Condition: Neck Squamous Cell Carcinoma of Unknown Primary; Recurrent Hypopharyngeal Squamous Cell Carcinoma; Recurrent Laryngeal Squamous Cell Carcinoma; Recurrent Laryngeal Verrucous Carcinoma; Recurrent Lip and Oral Cavity Squamous Cell Carcinoma; Recurrent Neck Squamous Cell Carcinoma of Unknown Primary; Recurrent Oral Cavity Verrucous Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma; Recurrent Salivary Gland Carcinoma; Recurrent Sinonasal Squamous Cell Carcinoma; Salivary Gland Squamous Cell Carcinoma; Stage IV Hypopharyngeal Squamous Cell Carcinoma AJCC v7; Stage IV Major Salivary Gland Cancer AJCC v7; Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7; Stage IVA Laryngeal Verrucous Carcinoma AJCC v7; Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7; Stage IVA Major Salivary Gland Cancer AJCC v7; Stage IVA Oral Cavity Cancer AJCC v6 and v7; Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7; Stage IVA Sinonasal Squamous Cell Carcinoma AJCC v7; Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7; Stage IVB Laryngeal Verrucous Carcinoma AJCC v7; Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7; Stage IVB Major Salivary Gland Cancer AJCC v7; Stage IVB Oral Cavity Cancer AJCC v6 and v7; Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7; Stage IVB Sinonasal Squamous Cell Carcinoma AJCC v7; Stage IVC Laryngeal Squamous Cell Carcinoma AJCC v7; Stage IVC Laryngeal Verrucous Carcinoma AJCC v7; Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7; Stage IVC Major Salivary Gland Cancer AJCC v7; Stage IVC Oral Cavity Cancer AJCC v6 and v7; Stage IVC Oropharyngeal Squamous Cell Carcinoma AJCC v7; Stage IVC Sinonasal Squamous Cell Carcinoma AJCC v7; Tongue Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Carcinoma, Verrucous; Salivary Gland Neoplasms; Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms; Neoplasms, Unknown Primary; Head and Neck Neoplasms; Recurrence
Intervention: Bevacizumab; Carboplatin; Cisplatin; Docetaxel; Fluorouracil; Laboratory Biomarker Analysis
Intervention description: Given IV; Given IV; Given IV; Given IV; Given IV; Correlative studies
Intervention MeSH terms: Bevacizumab; Antineoplastic Agents, Immunological; Cisplatin; Carboplatin; Docetaxel; Fluorouracil; Endothelial Growth Factors; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Immunoglobulin G
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 403.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies chemotherapy to see how well it works with or without
      bevacizumab in treating patients with head and neck squamous cell carcinoma that has come
      back (recurrent) or that has spread to other parts of the body (metastatic). Drugs used in
      chemotherapy, such as docetaxel, cisplatin, carboplatin, and fluorouracil, 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. Monoclonal antibodies, such as bevacizumab, may
      interfere with the ability of tumor cells to grow and spread. Bevacizumab may also make tumor
      cells more sensitive to chemotherapy and stop the growth of head and neck cancer by blocking
      blood flow to the tumor. It is not yet known whether combination chemotherapy is more
      effective when given with or without bevacizumab in treating patients with head and neck
      squamous cell carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed squamous cell cancer of
             the head and neck (SCCHN), from any primary site, including unknown primary cancers of
             the head and neck; patient must not have nasopharyngeal carcinoma of histologic types
             World Health Organization (WHO) 2 or 3 or squamous cell carcinoma that originated in
             the skin

          -  Patients must have SCCHN that is either (a) recurrent, judged incurable by surgery or
             radiation or (b) metastatic; NOTE: Patients who refuse radical resection for recurrent
             disease are eligible; NOTE: A second primary squamous cell carcinoma of the head and
             neck is allowed if eligibility is based on a recurrent or metastatic first primary
             squamous cell carcinoma of the head and neck

          -  No prior chemotherapy or biologic/molecular targeted therapy for recurrent or
             metastatic SCCHN

               -  Patients may have received one regimen of induction, concomitant
                  chemoradiotherapy and/or adjuvant chemotherapy as part of initial potential
                  curative therapy but must not have received prior chemotherapy for recurrent or
                  metastatic disease

               -  A minimum of 4 months is required between last dose of chemotherapy or
                  chemoradiotherapy and study treatment; in addition patients must be
                  progression-free for at least 4 months after completion of chemotherapy or
                  chemoradiotherapy or radiation plus cetuximab given with a curative intent;
                  (cetuximab therapy: 4 months is required between last dose of chemotherapy or
                  chemoradiotherapy and study treatment if part of concurrent regimen, 8 weeks if
                  part of adjuvant regimen post radiation)

               -  Patients having progression after 2 cycles of induction chemotherapy are not
                  eligible for the study

          -  No prior bevacizumab is allowed

          -  A maximum of one prior radiotherapy regimen, curative or palliative, to the head and
             neck is allowed; if the radiation is combined with chemotherapy and/or cetuximab, a
             minimum of 4 months must elapse between the end of radiotherapy and registration; if
             the radiation is given alone, a minimum of 8 weeks must elapse between the end of
             radiotherapy and registration; a minimum of 3 weeks must elapse between prior
             radiation to other areas and registration

          -  Patients must not be receiving any other investigational agent while on the study

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

          -  Patients must have recovered to grade 1 or better from any acute effects of prior
             surgery, chemotherapy, or radiation therapy, and should be > 4 weeks post surgery;
             chronic late xerostomia, speech and swallowing abnormalities resulting from prior
             radiation or surgery are permitted if nutritional status is stable

          -  Patients must have measurable disease based on Response Evaluation Criteria in Solid
             Tumors (RECIST); baseline measurements and evaluations of all sites of disease must be
             obtained =< 4 weeks prior to randomization; disease in previously irradiated sites is
             considered measurable if there has been unequivocal disease progression or
             biopsy-proven residual carcinoma following radiation therapy; persistent disease after
             radiotherapy must be biopsy proven at least 8 weeks after completion of radiation
             therapy; (radiographic findings are acceptable providing that clear-cut measurements
             can be made)

          -  Absolute neutrophil count (ANC) >= 1500/mm^3

          -  Hemoglobin (Hgb) >= 8.0 g/dL

          -  Platelet count >= 100,000/mm^3

          -  Creatinine clearance of >= 60 ml/min; creatinine clearance may be measured or
             calculated; if calculating, creatinine clearance, use the Cockroft-Gault formula

          -  Total bilirubin within normal limits (must be obtained =< 2 weeks prior to
             randomization)

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) must be within the
             range allowing for eligibility

               -  Alkaline phosphatase normal AND AST or ALT =< 5 x upper limit of normal (ULN)

               -  Alkaline phosphatase > 1 but =< 2.5 x ULN AND AST or ALT > 1 but =< 1.5 x ULN

               -  Alkaline phosphatase > 2.5 but =< 5 x ULN AND AST or ALT normal

          -  Alkaline phosphatase must be within the range allowing for eligibility

          -  Urine dipstick must be =< 0-1+ within 2 weeks (14 days) of randomization; if urine
             dipstick result is > 1+, a calculation of urine protein creatinine (UPC) ratio is
             required; patients must have a UPC ratio < 1.0 to participate in the study; NOTE: UPC
             ratio of spot urine is an estimation of the 24 urine protein excretion - a UPC ratio
             of 1 is roughly equivalent to a 24-hour urine protein of 1 gm

          -  No known brain metastases

          -  Patients who meet the following criteria will be excluded:

               -  Tumors that invade major vessels (e.g. the carotid) as shown unequivocally by
                  imaging studies

               -  Central (i.e. within 2 cm from the hilum) lung metastases that are cavitary as
                  shown unequivocally by imaging studies

               -  Any prior history of bleeding related to the current head and neck cancer

               -  History of gross hemoptysis (bright red blood of 1/2 teaspoon or more per episode
                  of coughing) =< 3 months prior to enrollment

          -  No history of coagulopathy or hemorrhagic disorders

          -  Patients should not have a history of thrombosis (e.g. pulmonary embolism or deep
             venous thrombosis) currently requiring therapeutic anticoagulation (prophylactic use
             of warfarin 1 mg per day is allowed) and international normalized ratio (INR) should
             be < 1.5 at registration

          -  Patients must not be receiving chronic daily treatment with aspirin (> 325 mg/day) or
             non-steroidal anti-inflammatory agents (NSAID's) known to inhibit platelet function;
             the use of anti-platelet agents (e.g. dipyridamole [Persantine], ticlopidine [Ticlid],
             clopidogrel [Plavix]) is allowed only if patient is not receiving aspirin or NSAID's
             known to inhibit platelet function

          -  No hypercalcemia related to head and neck cancer

          -  Patients with a prior history of squamous cell or basal carcinoma of the skin or in
             situ cervical cancer must have been curatively treated; patients with a history of
             other prior malignancy must have been treated with curative intent and must have
             remained disease-free for 3 years post diagnosis

          -  No current peripheral neuropathy >= grade 2 at time of randomization

          -  Patients must not have any co-existing condition that would preclude full compliance
             with the study

          -  No prior history of severe hypersensitivity reaction to docetaxel or other drugs
             formulated with polysorbate 80, if the physician's choice of chemotherapy regimen is
             docetaxel

          -  All patients must have blood pressure =< 150/90 =< 2 weeks prior to randomization;
             patients with history of hypertension must be well-controlled upon study entry (=<
             150/90) on a stable regimen of anti-hypertensive therapy

          -  No major surgical procedure, open biopsy, or significant traumatic injury within 28
             days prior to study enrollment, or anticipation of need for major surgical procedure
             during the course of the study

          -  No unstable angina or myocardial infarction within the previous 6 months; no
             symptomatic congestive heart failure, New York Heart Association (NYHA) grade II or
             greater; no history of aortic dissection or presence of aneurysm > 6 cm (or at high
             risk for rupture); no serious cardiac arrhythmia requiring medication (history of
             chronic atrial fibrillation or other atrial arrhythmia with controlled rate on
             medication is allowed); no clinically significant peripheral vascular disease
             manifested by intermittent claudication or need for vascular intervention; no history
             of aortic dissection; no history of any central nervous system (CNS) cerebrovascular
             ischemia or stroke within the last 6 months; no active serious infection

          -  Patients should not have prior history of a serious human anti-human antibody (HAHA)
             reaction; patients with known hypersensitivity to Chinese hamster ovary cell products
             or other recombinant human antibodies are not eligible

          -  Women must not be pregnant or breast feeding; pregnant women are excluded from this
             study; women of child-bearing potential and men must agree to total abstinence or to
             use adequate hormonal or barrier method of birth control prior to study entry and for
             the duration of study participation; should a woman become pregnant or suspect she is
             pregnant while in this study, she should inform her treating physician immediately;
             all females of childbearing potential must have a blood test or urine study within 2
             weeks prior to randomization to rule out pregnancy

          -  Human immunodeficiency virus (HIV)-positive patients receiving combination
             anti-retroviral therapy are excluded from the study; appropriate studies will be
             undertaken in patients receiving combination anti-retroviral therapy when indicated

          -  No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal
             abscess within 6 months prior to registration