TheranosticTrials.org

Clinical Trial · NCT01320683

Combination Chemotherapy and Bevacizumab Before Surgery and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer

Overview

This phase II trial studies how well giving combination chemotherapy and bevacizumab before surgery and radiolabeled monoclonal antibody therapy works in treating liver metastases in patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A, can find tumor cells and carry tumor-killing substances to them without harming normal cells. Giving chemotherapy and monoclonal antibody before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiolabeled monoclonal antibody therapy after surgery may kill any tumor cells that remain after surgery

Sponsor

City of Hope Medical Center

Phase

Phase 2

Contacts

Jeffrey Wong (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01320683

Drug / Compound

M5A anti-CEA monoclonal antibody

Isotope(s):
Target(s):
  • CEA
Ligand Class: Antibodies
Chelator: DOTA

M5A

Isotope(s):
Target(s):
  • CEA
Ligand Class: Antibodies
Chelator: DOTA

Eligibility

Inclusion

  • White blood cell (WBC) \>= 4000/uL
  • If a patient has previously received murine or chimeric antibody, then serum anti-antibody testing must be negative
  • Absolute neutrophil count (ANC) \>= 1,500/mm\^3
  • Women of childbearing potential must have a negative serum pregnancy test prior to entry and while on study must be practicing an effective form of contraception
  • Patients must have no prior history of radiation therapy to the liver (includes 90Y microsphere therapy)
  • Prior radiotherapy, immunotherapy, or chemotherapy must have been completed between 4-12 weeks prior to patient entry on this study and patients must have recovered from all expected acute side effects of the prior therapy
  • Patients may have history of prior malignancy for which the patient has been disease-free for five years; basal or squamous cell skin cancers or carcinoma in situ of the cervix are allowed regardless of diagnosis date
  • Patients must have a Karnofsky performance status of \>= 60%
  • Platelets \>= 150,000/ul
  • Serum creatinine of =\< 1.5 x upper limit of normal (ULN)
  • Patients must have had \< 40% liver resected at the close of completion of the hepatic resection; this will be verified retrospectively
  • Patients must have a total bilirubin =\< 1.5 mg/dL
  • Computed tomography (CT) scan restaging done prior to RIT must demonstrate no evidence of progressive disease
  • Patients will be enrolled on this trial after resection of hepatic metastases combined with FOLFIRI or FOLFOX \[+/- Bevacizumab\], or XELOX; patients may have received a maximum of 12 cycles of FOLFIRI or FOLFOX \[+/- Bevacizumab\], or XELOX, which includes chemotherapy prior to and post hepatic resection
  • Patients must have histological confirmation of colorectal carcinoma
  • Patients must have colorectal tumors that produce carcinoembryonic antigen (CEA) as documented by either immunohistochemistry or by an elevated serum CEA
  • Hemoglobin \>= 10 gm %; patients may be transfused to reach a hemoglobin \>= 10 gm %
  • Serum human immunodeficiency virus (HIV) testing and hepatitis B surface antigen and hepatitis C antibody testing must be negative

Exclusion

  • Chronic active hepatitis, cirrhosis, or chemotherapy steatohepatitis
  • Patients that have received radiation therapy to greater than 50% of their bone marrow
  • Patients with any nonmalignant intercurrent illness (example cardiovascular, pulmonary, or central nervous system disease) which is either poorly controlled with currently available treatment or which is of such severity that the investigators deem it unwise to enter the patient on protocol shall be ineligible