Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers

Subjects must have histologically or cytologically confirmed diagnoses of adenocarcinoma in one of the following scenarios:

* Primary tumors of the pancreas

* Primary tumors of the bile duct and ampulla

* Metastatic colorectal cancers to the liver

Subjects must have disease resectable with a standard pancreatectomy (pancreaticoduodenectomy or distal pancreatectomy) or liver resection.

Subjects may have received prior therapy, including neoadjuvant regimens.

Subjects must have serum Carbohydrate antigen 19-9 (CA 19-9) elevations greater than the upper limit of normal but less than 2500 U/mL.

Age greater than or equal to 18 years.

Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1

Subjects must have adequate organ and marrow function as defined below:

* leukocytes \>3,000/mcL

* absolute neutrophil count \>1,500/mcL

* platelets \>90,000/mcL

For subjects with Periampullary cancers that require a pancreaticoduodenectomy for complete tumor extirpation:

* total bilirubin \<10 upper limit of normal (ULN)\*

* Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT)/alanine aminotransferase (ALT) serum glutamate-pyruvate transaminase (SGPT) \<5 X institutional upper limit of normal

* creatinine \<1.5X institutional upper limit of normal

* Subjects with periampullary cancers typically present with biliary obstruction resulting in significant abnormalities in liver function tests that do not reflect liver dysfunction. These values normalize after tumor removal. They can be normalized pre-operatively with biliary stenting, but several large studies have demonstrated an increase in infectious complications with drainage. As such, a practice standard has been to avoid stenting until bilirubin level rises above 10 X ULN.

For subjects with liver tumors (cholangiocarcinoma or metastatic colorectal cancer) requiring a hepatectomy for complete tumor extirpation:

* total bilirubin \<2.5 X institutional upper limit of normal\*

* AST(SGOT)/ALT(SGPT) \<5 X institutional upper limit of normal\*

* creatinine \<1.5X institutional upper limit of normal

* Liver abnormalities in this range are consistent with parenchymal destruction from the tumor.

For subjects with pancreas tumors that require a distal pancreatectomy for extirpation:

* total bilirubin \<1.5 X institutional upper limit of normal\*

* AST(SGOT)/ALT(SGPT) \<2 X institutional upper limit of normal\*

* creatinine \<1.5X institutional upper limit of normal

* Liver abnormalities in this range are consistent with pancreas cancer destruction from the tumor.

The effects of MVT-5873 (HuMab-5B1) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 3 months after completion of study treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.

Ability of subject to understand and the willingness to sign a written informed consent document.

Subjects must agree to co-enrollment on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors.

What this study is about