Status:
COMPLETED
Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Advanced Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 advance...
Detailed Description
The Study Drugs: Oxaliplatin is designed to keep new cancer cells from growing. Capecitabine is designed to interfere with the growth of cancer cells. Bevacizumab is designed to block the growth of...
Eligibility Criteria
Inclusion
- Patients must have histologically confirmed cancer with predominant liver metastases.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (capable of all self care but unable to carry out any work activities).
- Adequate renal function (creatinine clearance \>50 mL/min).
- Adequate liver function: total bilirubin \</= 4 mg/dL, alanine transaminase (ALT) \</= 5 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.
- Adequate bone marrow function (absolute neutrophil count (ANC) \>/= 1000 cells/uL; platelets (PLT) \>/= 70,000 cells/uL).
- 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.
- 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.
- Ability and willingness to sign informed consent form.
- Must be \>/= 18 years of age.
- 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
- Pregnant females.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- 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.
- Patients already in uncompensated liver failure (i.e., Child Pugh Liver Classification C).
- History of hypersensitivity to any component of the formulation.
- Exclusion criteria only for patients enrolled in Arm 1: Serious or non-healing wound, ulcer, or bone fracture.
- 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.
- 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).
- Exclusion criteria only for patients enrolled in Arm 1: History of bleeding CNS metastases.
Key Trial Info
Start Date :
September 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 26 2018
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT01213238
Start Date
September 30 2010
End Date
September 26 2018
Last Update
March 15 2019
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030