Overview

Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab

Status:
Completed

Trial end date:
2018-09-26

Target enrollment:
0

Participant gender:
All

Summary

The goal of this clinical research study is to find the highest tolerable dose of the combination of oxaliplatin and capecitabine with or without bevacizumab that can be given to patients with advanced cancer that has spread to the liver. The safety of these drug combinations will also be studied.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Treatments:

Antibodies
Antibodies, Monoclonal
Bevacizumab
Capecitabine
Oxaliplatin

Criteria

Inclusion Criteria:

1. Patients must have histologically confirmed cancer with predominant liver metastases.

2. Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self
care but unable to carry out any work activities).

3. Adequate renal function (creatinine clearance >50 mL/min).

4. Adequate liver function: total bilirubin times upper normal reference value. Patients with total bilirubin between 3.0 and 4.0
mg/dL must have blood ammonia level checked at baseline. Blood ammonia level must be
within normal limits for enrollment.

5. Adequate bone marrow function (absolute neutrophil count (ANC) >/= 1000 cells/uL;
platelets (PLT) >/= 70,000 cells/uL).

6. At least 3 weeks from prior cytotoxic chemotherapy or radiation therapy. If targeted
or biologic therapy, there should be at least 5 half lives or 3 weeks, whichever is
shorter, from day 1 of treatment.

7. All females in childbearing age MUST have a negative urine human chorionic
gonadotropin (HCG) test before the first dose, unless prior hysterectomy or menopause
(defined as age above 55 and six months without menstrual activity). Patients should
not become pregnant or breast-feed while on this study. Sexually active patients
should use effective birth control.

8. Ability and willingness to sign informed consent form.

9. Must be >/= 18 years of age.

10. Patients with unresectable liver-only (isolated liver) metastases are eligible; those
who show adequate response may be considered for liver resection and/or radiofrequency
ablation (RFA) of remaining disease.

Exclusion Criteria:

1. Pregnant females.

2. Inability to complete informed consent process and adhere to protocol treatment plan
and follow-up requirements.

3. Uncontrolled intercurrent illness, including, but not limited to, ongoing or active
infection requiring parental antibiotics, or psychiatric illness/social situations
that would limit compliance with study requirements.

4. Patients already in uncompensated liver failure (i.e., Child Pugh Liver Classification
C).

5. History of hypersensitivity to any component of the formulation.

6. Exclusion criteria only for patients enrolled in Arm 1: Serious or non-healing wound,
ulcer, or bone fracture.

7. Exclusion criteria only for patients enrolled in Arm 1: Any history of abdominal
fistula or gastrointestinal perforation; or intra-abdominal abscess within 28 days of
enrollment.

8. Exclusion criteria only for patients enrolled in Arm 1: Uncontrolled systemic vascular
hypertension (systolic blood pressure > 140 mm Hg, diastolic Blood Pressure > 90 mm
Hg).

9. Exclusion criteria only for patients enrolled in Arm 1: History of bleeding CNS
metastases.