Bortezomib With or Without Irinotecan in Treating Patients With Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Condition: Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IV Verrucous Carcinoma of the Larynx; Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVA Squamous Cell Carcinoma of the Oropharynx; Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVA Verrucous Carcinoma of the Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Oropharynx; Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVB Verrucous Carcinoma of the Oral Cavity; Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVC Squamous Cell Carcinoma of the Oropharynx; Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVC Verrucous Carcinoma of the Oral Cavity; Tongue Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Laryngeal Neoplasms; Oropharyngeal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Verrucous; Nasopharyngeal Carcinoma; Paranasal Sinus Neoplasms; Tongue Neoplasms; Laryngeal Diseases; Recurrence
Intervention: bortezomib; irinotecan hydrochloride; laboratory biomarker analysis
Intervention description: Given IV; Given IV; Optional correlative studies
Intervention MeSH terms: Irinotecan; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial is studying bortezomib and irinotecan to see how well they
      work compared to bortezomib alone in treating patients with locally recurrent or metastatic
      squamous cell carcinoma of the head and neck. Bortezomib may stop the growth of tumor cells
      by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as
      irinotecan, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving bortezomib together with irinotecan may kill
      more tumor cells. It is not yet known whether giving bortezomib together with irinotecan is
      more effective than bortezomib alone in treating head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients may have had one (0-1) prior chemotherapy regimen for recurrent or metastatic
             SCCHN; chemotherapy for recurrent or metastatic disease must have been completed at
             least 4 weeks prior to study entry

          -  Patients must not have been previously treated with irinotecan or bortezomib

               -  Patients must not be receiving radiation treatment

          -  Patients must have histologically confirmed squamous cell carcinoma of the head and
             neck

          -  Patients must have biopsy for histological confirmation of recurrent or metastatic
             disease if disease is now recurrent or metastatic after prior disease free-interval

               -  NOTE: If patient has had a complete response (of any duration) but now has
                  suspected recurrent disease (regardless of the time interval), the patient will
                  need a biopsy for confirmation of SCCHN

          -  Disease must not be amenable to potentially curative local therapies or patient must
             have refused such options

          -  Patients must not have nasopharyngeal subtypes WHO II or III. Patients may have
             nasopharyngeal WHO I; salivary gland primaries are excluded from study SUBTYPES OF
             NASOPHARYNGEAL CARCINOMA (NPC) WHO type 1 - keratinizing SCC WHO type 2 -
             nonkeratinizing epidermoid carcinoma WHO type 3 - undifferentiated carcinoma

          -  Patients must have measurable disease

               -  Baseline measurements and evaluations must be obtained within 4 weeks of
                  registration to the study

               -  Measurable disease limited to a pre-irradiated location must be biopsy proven to
                  be squamous cell carcinoma

          -  Must have at least one objective measurable disease parameter; baseline measurements
             and evaluations must be obtained within 4 weeks of registration to the study; all
             areas of disease should be recorded and mapped out in order to assess response and
             uniformity of response to therapy

               -  Radiographic findings are acceptable providing that clear-cut measurement can be
                  made

               -  Measurable disease limited to a pre-irradiated location must be biopsy-proven to
                  be squamous cell carcinoma

          -  Patients must have ECOG performance status 0 or 1

          -  Patients must not have grade 2 or higher peripheral neuropathy within 2 weeks of study
             entry

          -  Leukocytes >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Total bilirubin within normal institutional limits

          -  AST(SGOT) and ALT(SGPT) =< 2.5 x institutional upper limit of normal

          -  Creatinine within normal institutional limits OR

          -  Creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above
             institutional normal

          -  Patients must have had no prior invasive malignancy unless the disease-free interval
             is 5 years or more

          -  Women must not be pregnant or breast-feeding due to the fact that the teratogenic or
             abortifacient effects of PS-341are unknown; the effect of PS-341 on the nursing infant
             are also unknown; all females of childbearing potential must have a blood test or
             urine study within 2 weeks prior to registration to rule out pregnancy

          -  Women of childbearing potential and sexually active males must be strongly advised to
             use an accepted and effective method of contraception for the duration of study
             participation; should a woman become pregnant or suspect she is pregnant while
             participating in this study, she should inform her treating physician immediately

          -  Patients with known brain metastases will be excluded from this clinical trial because
             of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events

          -  Patients must not have history of allergic reactions to PS-341 or allergic reaction
             attributed to compounds of similar chemical or biologic composition to PS-341
             including boron or mannitol

          -  Patients must not have uncontrolled intercurrent illness including, but not limited
             to, ongoing or active infection, unstable angina pectoris, or psychiatric
             illness/social situations that would limit compliance with study requirements

          -  ELIGIBILITY FOR RE-REGISTRATION TO ARM A (FOR ARM B PATIENTS AT THE TIME OF
             PROGRESSION

               -  Patients must have ECOG performance status 0 or 1

               -  Leukocytes >= 3,000/uL

               -  Absolute neutrophil count >- 1,500/uL

               -  Platelets >= 100,000/uL

               -  Total bilirubin within normal institutional limits

               -  AST(SGOT) and ALT(SGPT) =< 2.5 x institutional upper limit of normal

               -  Creatinine within normal institutional limits OR creatinine clearance >= 60
                  mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

               -  Patients with known brain metastases will be excluded from this clinical trial
                  because of their poor prognosis and because they often develop progressive
                  neurologic dysfunction that would confound the evaluation of neurologic and other
                  adverse events