Axitinib (AG-013736) in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

Inclusion Criteria

• •Patients must have MSKCC pathologically confirmed adenoid cystic carcinoma. Cancers arising from non-salivary gland primary sites are allowed.
• •Patients must have locally advanced and/or recurrent and/or metastatic disease not amenable to potentially curative surgery or radiotherapy.
• •At least 2 weeks must have elapsed since the end of prior systemic treatment (4 weeks for bevacizumab- containing regimens), radiotherapy, or surgical procedure with resolution of all treatment-related toxicity to NCI CTCAE Version 4.0 grade ≤1 (or tolerable grade 2) or back to baseline except for alopecia or hypothyroidism.
• •Patients must have RECIST v1.1 measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \> or = to 20 mm with conventional techniques or as \> or = to 10 mm with spiral CT scan.
• •Patients must have documentation of a new or progressive lesion on a radiologic imaging study performed within 6 months prior to study enrollment (progression of disease over any interval is allowed) and/or new/worsening disease related symptoms. Note: This assessment will be performed by the treating investigator. Evidence of progression by RECIST criteria is not required.
• •Patients must have archival tissue from the primary tumor or metastases available for correlative studies. Either a paraffin block or twenty unstained slides containing 5μm sections are acceptable. If twenty slides are not available, a lesser amount may be acceptable after discussion with the study Principal Investigator, Dr. Alan L. Ho.
• •Male or female, age \> or = to 18 years.
• •ECOG performance status \< or = to 2 (Karnofsky \> or = to 60%, see Appendix A).
• •Life expectancy of ≥ 12 weeks.
• •Adequate organ function as defined by the following criteria:
• •absolute neutrophil count (ANC) \> 1000 cells/mm3
• •platelets \> or = to 75,000 cells/mm3
• •Hemoglobin \> or = to 9.0 g/dL
• •AST and ALT \< or = to 2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT \< 5.0 x ULN
• •Total bilirubin \< or = to 1.5 x ULN
• •Serum creatinine \< or = to 1.5 x ULN or calculated creatinine clearance \> or = to 60 ml/min
• •Urinary protein \< 2+ by urine dipstick. If dipstick is \> or = to 2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is \< 2 g per 24 hours.
• •Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after discontinuing study treatment.