Alkaline phosphatase =< 1.5 x the institutional ULN Alkaline phosphatase (ALK Phos) =< 2.5 x institutional ULN Alkaline phosphatase =< 1.5 x IULN within 28 days prior to registration Within 6 weeks prior to randomization: Alkaline phosphatase must be =< 2.5 x ULN for the lab Alkaline phosphatase =< 2.5 x ULN (CTCAE v 3.0 grade 0-1) Alkaline phosphatase =< 3 x ULN Alkaline phosphatase =< 1.5 x institutional ULN, within 21 days prior to registration Alkaline phosphatase =< 2 x IULN Patients must have alkaline phosphatase =< 2.5 x IULN within 14 days prior to registration Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1) Alkaline phosphatase =< 3X the institutional ULN Alkaline phosphatase ? 2.5 x ULN, unless the elevated alkaline phosphatase is due to bone metastasis. Alkaline phosphatase ? 2.5 × ULN; Alkaline phosphatase =< 2 × ULN (=< 5 × ULN if considered due to tumor) Alkaline phosphatase < 5 times ULN AST and/or ALT > 1.5 x ULN with concomitant alkaline phosphatase > 2.5 x ULN Serum alkaline phosphatase =< 5 x institutional ULN Alkaline phosphatase =< 3 × ULN Alkaline phosphatase > 3 ULN Alkaline phosphatase should be less than or equal to 2.5 x ULN (CTCAE v4.0, grade 1) Have an alanine aminotransferase (ALT) ?3.0 × ULN. (Note: There are no specific requirements for AST or alkaline phosphatase.) alkaline phosphatase must be ? 2.5 x ULN for the lab; and Alkaline phosphatase =< 2.5 x ULN; (=< 5 x ULN in case of bone metastasis) Alkaline phosphatase =< 2.5 x ULN, within 14 days prior to registration Alkaline phosphatase =< 2.5 x ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) with alkaline phosphatase =< 2.5 x ULN OR AST and ALT =< 1.5 x ULN, with alkaline phosphatase > 2.5 x ULN ARM 2 - A: AST/ALT/alkaline phosphatase: =< 5 x ULN Alkaline phosphatase =< 3 x ULN =< 28 days prior to registration Alkaline phosphatase up to 2.5 x ULN. COHORT B ONLY: Obtained =< 14 days prior to registration: alkaline phosphatase =< 750 U/L Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase less than 1.5 times ULN (grade 1) Alkaline phosphatase =< 2.5 x ULN ALT or aspartate AST > 1.5 x ULN concomitant with alkaline phosphatase > 2.5 x ULN AST and ALT =< 1.5 x ULN, with alkaline phosphatase > 2.5 x ULN Alkaline phosphatase < 2.5 × ULN Serum alkaline phosphatase =< 5 X ULN Obtained =< 14 days prior to registration: Alkaline phosphatase =< 3 x ULN Alkaline phosphatase =< 2.5 x ULN for the institution within 14 days of study registration Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4.03 grade 1) Alkaline phosphatase =< 5 x ULN must be met during screening (within 21 days) and also prior to study drug administration on cycle 1 day 1 Within 14 days prior to registration: Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase < 4 x ULN. Alkaline phosphatase (alk phos) < 2.5 X ULN Alkaline phosphatase =< 2.5 X ULN Alkaline (Alk) phosphatase < 2.5 x ULN Hepatic impairment, defined as alkaline phosphatase =< 2 x institutional ULN, within 21 days of initiation of protocol therapy Hepatic impairment, defined as alkaline phosphatase > 2 x institutional ULN, within 21 days of initiation of protocol therapy Alkaline phosphatase =< 3 x ULN Determined within 3 weeks of treatment initiation: Alkaline phosphatase < 5 x ULN Alkaline phosphatase =< 2.5 x ULN prior to biopsy Obtained =< 7 days prior to registration: Alkaline phosphatase < 5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase < 3 x ULN Alkaline phosphatase > 2.5 x ULN Alkaline phosphatase =< to 2.5 x ULN Alkaline phosphatase < 5 x ULN obtained =< 7 days prior to registration Alkaline phosphatase =< 2.5 x institutional ULN obtained within 14 days of first treatment Alkaline phosphatase =< 2.5 x ULN, unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase (Alk phos) =< 5 X ULN Alkaline Phosphatase less than 2.5 x ULN (CTCAE Grade 1) Alkaline phosphatase (liver fraction) =< 2.5 X ULN; if AST or ALT is > 2.5 X ULN, then liver fraction of alkaline phosphatase should be =< 2.5 X ULN Alkaline phosphatase > 2.5 x ULN Alkaline phosphatase (AP) ? 2.5 x ULN, unless considered due to organ leukemic involvement; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) with alkaline phosphatase =< 2.5 x ULN OR AST and ALT =< 1.5 x ULN, with alkaline phosphatase > 2.5 x ULN Alkaline phosphatase (alk phos) < 2.6 x ULN Alkaline phosphatase =< 1.5 x ULN, obtained =< 14 days prior to registration Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase < 5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 ULN Alkaline phosphatase > 2.5 x ULN Alkaline phosphatase < 5 x ULN Alkaline phosphatase < 2.5 x ULN Serum alkaline phosphatase =< 5 x ULN Alkaline phosphatase < 5 x ULN Alkaline phosphatase =< 2 x ULN or considered not clinically significant Obtained =< 14 days prior to registration: Alkaline phosphatase =< 750 U/L Alkaline phosphatase ?2.0×ULN. Alkaline phosphatase ?5 x ULN ORAL CAVITY SQUAMOUS CELL CARCINOMA COHORT: Alkaline phosphatase < 2 x ULN Alkaline phosphatase < 2.5 X ULN Alkaline phosphatase < 252 u/L Alkaline phosphatase < 2.0 x ULN Alkaline phosphatase must be =< 3 x ULN for the lab within 28 days before randomization Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase (ALK Phos) < 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN; if liver involvement, alkaline phosphatase =< 5.0 x ULN Alkaline phosphatase =< 2.5 x ULN for the institution Alkaline phosphatase must be =< 2.5 x ULN for the lab Alkaline phosphatase and AST may not both be > the ULN; for example, if the alkaline phosphatase is > the ULN but =< 2.5 x ULN, the AST must be =< the ULN; if the AST is > the ULN but =< 1.5 x ULN, the alkaline phosphatase must be =< ULN; Note: If alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be =< 1.5 x ULN; if both were performed, the AST must be =< 1.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase less than or equal to 2.5 x ULN (CTEP CTCAE version 4.0, grade 1) Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase >= 2 x institutional ULN, within 21 days of initiation of protocol therapy Alkaline phosphatase =< 2.5 x upper limit of normal (ULN); patients with hepatic and/or bone metastases: alkaline phosphatase =< 5 x ULN Alkaline phosphatase >= 2 x ULN Alkaline phosphatase =< 2 x IULN be obtained within 42 days prior to registration Alkaline phosphatase =< 1.5 x ULN (institutional) Alkaline phosphatase ? 5 x ULN Alkaline phosphatase =< 2.5 x ULN for the institution Alkaline phosphatase less than or equal to 2.5 x ULN Alkaline phosphatase greater than 2.5 x ULN (CTCAE v4.0 grade 1) (if known hepatic metastases alkaline phosphatase may be =< 5 x ULN) Alkaline phosphatase* less than or equal to 2.5 x ULN Alkaline phosphatase =< 1.5 UNL alkaline phosphatase must be less than or equal to 2 x ULN; and Alkaline phosphatase < 5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase ?2.0×ULN Alkaline phosphatase limit ? 2.5 x ULN Alkaline phosphatase less than or equal to 3 x ULN Alkaline phosphatase less than or equal to 2.5 x ULN Alkaline phosphatase < or equal to 4 x ULN if not related to leukemic disease Alkaline phosphatase ? 2.5 x ULN Alkaline phosphatase within 5 times ULN Alkaline phosphatase ? 5X ULN Alkaline phosphatase =< 2.5 x ULN Alkaline (Alk.) phosphatase =< 3 x ULN Alkaline phosphatase: ? 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN obtained =< 14 days prior to registration Alkaline phosphatase > 3 x institutional ULN, within 21 days of initiation of protocol therapy Alkaline phosphatase =< 3 x ULN Alkaline phosphatase (AP) =< 2.0 x ULN Alkaline phosphatase < 2 X institutional ULN Alkaline phosphatase < 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 5 x ULN Alkaline phosphatase =< 5.0 x ULN Alkaline phosphatase =< 1.5 x IULN Alkaline phosphatase < 5 x ULN Alkaline phosphatase >= 2.5 times ULN Alkaline phosphatase > 3 x ULN Alkaline phosphatase > 2 x institutional ULN Alkaline phosphatase =< 2.5 x ULN Serum alkaline phosphatase should be =< 1.5 x institutional ULN Alkaline phosphatase (Alk Phos) =< 2.5 x ULN Alkaline (Alk) phosphatase < 2.5 x ULN Obtained =< 7 days prior to registration: Alkaline phosphatase =< 3 x ULN Alkaline phosphatase >= 3 x ULN Alkaline phosphatase ? 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 X ULN Alkaline phosphatase =< 2.5 x ULN for the institution Alkaline phosphatase =< 2.5 x ULN, CTCAE grade 1 Alkaline phosphatase < 2.5 x ULN Alkaline phosphatase no greater than 1.5 times ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase less than or equal to 2.5 x ULN Alkaline phosphatase values within the institutional ULN Alkaline phosphatase =< 2.5 X ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase < 2.5 x ULN Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and alkaline phosphatase must be within the eligible; in determining eligibility, the more abnormal of the two values (AST or ALT) should be used; patients with alkaline phosphatase elevation secondary to the bony metastases rather than liver dysfunction may proceed with treatment on protocol after discussion with the principal investigator Alkaline phosphatase > 1 x ULN but =< 2.5 x ULN and AST or ALT =< ULN eligible Alkaline phosphatase > 2.5 x ULN but =< 5 x ULN and AST or ALT =< ULN eligible Alkaline phosphatase > 5 x ULN and AST or ALT =< ULN ineligible Alkaline phosphatase =< ULN and AST or ALT > 1 x ULN but =< 1.5 x ULN eligible Alkaline phosphatase > 1 x ULN but =< 2.5 x ULN and AST or ALT > 1 x ULN but =< 1.5 x ULN eligible Alkaline phosphatase > 2.5 x ULN but =< 5 x ULN and AST or ALT > 1 x ULN but =< 1.5 x ULN ineligible Alkaline phosphatase > 5 x ULN and AST or ALT > 1 x ULN but =< 1.5 x ULN ineligible Alkaline phosphatase =< ULN and AST or ALT > 1.5 x ULN but =< 5 x ULN eligible Alkaline phosphatase > 1 x ULN but =< 2.5 x ULN and AST or ALT > 1.5 x ULN but =< 5 x ULN ineligible Alkaline phosphatase > 2.5 x ULN but =< 5 x ULN and AST or ALT > 1.5 x ULN but =< 5 x ULN ineligible Alkaline phosphatase > 5 x ULN and AST or ALT > 1.5 x ULN but =< 5 x ULN ineligible Alkaline phosphatase =< ULN and AST or ALT > 5 x ULN ineligible Alkaline phosphatase > 1 x ULN but =< 2.5 x ULN and AST or ALT > 5 x ULN ineligible Alkaline phosphatase > 2.5 x ULN but =< 5 x ULN and AST or ALT > 5 x ULN ineligible Alkaline phosphatase > 5 x ULN and AST or ALT > 5 x ULN ineligible Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4.0 grade 1) Alkaline phosphatase < 3 x ULN Alkaline phosphatase =< 2 X ULN Alkaline phosphatase =< 2.5 times ULN Alkaline phosphatase ? 2.5 times the ULN Alkaline phosphatase =< 2.5 x ULN for the institution Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x IUNL Alkaline phosphatase (AP) must be within the range allowing for eligibility, as follows:\r\n* =< ULN\r\n* =< 2.5 x ULN\r\n* =< 5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 3.0 x ULN; if liver involvement, alkaline phosphatase =< 5.0 x ULN Alkaline phosphatase must be =< 2.5 x ULN for the lab Alkaline phosphatase and AST/ALT may not both be > the ULN; for example, if the alkaline phosphatase is > the ULN but =< 2.5 x ULN, then the AST/ALT must be =< the ULN; if the AST/ALT is > the ULN but =< 1.5 x ULN, then the alkaline phosphatase must be =< ULN Patients with AST/ALT or alkaline phosphatase > ULN must have liver imaging that does not demonstrate metastatic disease Alkaline phosphatase above 2.5X the ULN Alkaline phosphatase =< 5 x UNL Alkaline phosphatase of =< 2 ULN The subject has aspartate aminotransferase and/or alanine aminotransferase > 1.5 × ULN, with concomitant alkaline phosphatase > 2.5 × ULN. Alkaline phosphatase limit =< 2.5 x ULN Alkaline phosphatase (Alk phos) =< 3.0 x ULN Alkaline phosphatase =< to 2.5 x ULN Alkaline phosphatase =< 5 x institutional ULN obtained =< 7 days prior to registration Part 2 only: plasma total bilirubin <= ULN; ALT and/or AST <= 1.5 X ULN concomitant with alkaline phosphatase <= 2.5 X ULN. Part 2 only: Patients with plasma total bilirubin > ULN; ALT and/or AST > 1.5 X ULN concomitant with alkaline phosphatase > 2.5 X ULN. Alkaline phosphatase =< 2.5 × ULN (patients with hepatic and/or bone metastases: alkaline phosphatase =< 5 × ULN) Liver: hepatomegaly on physical exam with elevated alkaline phosphatase > 1.5 x ULN Alkaline phosphatase ? 5 x ULN Alkaline phosphatase < 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase =< 2.5 x ULN; except for patients with hepatic and/or bone metastases: alkaline phosphatase =< 5 x ULN Alkaline phosphatase < 2 x ULN (< 5 x ULN in subjects whom the PI and sponsor agree that clinical data suggest extrahepatic source of elevation) Alkaline phosphatase (AP) =/< 2.5 x ULN Alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE grade 1) Alkaline phosphatase =< 1.5 x ULN Alkaline phosphate =< 2.5 x ULN (within four weeks prior to the study) Alkaline phosphatase < 2 times ULN, unless arising from bone Alkaline phosphatase =< 5 x ULN Alkaline phosphatase =< 2.5 x ULN Alkaline phosphatase limit =< 2.5 x ULN Alkaline phosphatase < 2 times ULN, unless arising from bone Alkaline phosphatase less than or equal to 2.5 x ULN Alkaline phosphatase limit =< 2.5 x ULN Serum alkaline phosphatase < 2 x ULN, or considered not clinically significant by the study doctor or designee Alkaline phosphate > 1.5 x ULN Patients with plasma alkaline phosphatase greater than 190 IU/dL Alkaline phosphatase =< 2.5 x ULN Serum alkaline phosphatase level >= 300 IU/L. Alkaline phosphatase ? 2.5 x ULN Alkaline phosphatase < 5 x ULN Alkaline phosphatase < 4 x ULN Alkaline phosphatase =< 1.5 x ULN Alkaline phosphatase < 2 x ULN Alkaline phosphatase < 2 x ULN Alkaline phosphatase =< 1.5 x institutional ULN Alkaline phosphatase > 2.5 x ULN Alkaline phosphatase < 2.5 x ULN Alkaline phosphatase =< 2.5 time ULN Alkaline phosphatase =< 2 X ULN Alkaline phosphatase =< 2.5 x IULN Alkaline phosphatase (ALK phos) within 2 x ULN Alkaline phosphatase =< 2.5 x IULN Alkaline phosphatase (AP) =< 3 X ULN, obtained within 14 days prior to PET scan Alkaline phosphatase < 3 x ULN Alkaline phosphatase =< 5 x ULN Alkaline phosphatase < 2.5 x ULN Alkaline phosphatase =< 190 IU/dL Patients with plasma alkaline phosphatase greater than 190 IU/dL Alkaline phosphatase ? 2.5 x ULN