Status:
COMPLETED
Hepatic Arterial Infusion Oxaliplatin + 5FU, Leucovorin, and Bevacizumab +/- Cetuximab
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Advanced Cancers
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the best combination of oxaliplatin, bevacizumab, 5-fluorouracil, leucovorin, and cetuximab that can be given to patients with advanced cancer that ...
Detailed Description
The Study Drugs: Oxaliplatin is designed to keep new cancer cells from growing. 5-fluorouracil is designed to block the way cancer cells grow and divide, which may slow or stop their growth and keep...
Eligibility Criteria
Inclusion
- Patients must have histologically confirmed cancer with metastatic liver metastases.
- Patients should be refractory to standard therapy, relapsed after standard therapy, or have no standard therapy that increases survival by at least 3 months, unless the drugs in the protocol regimen are part of the standard of care.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2 (Capable of all self care but unable to carry out any work activities). Pediatric: performance status Karnovsky (\>10) or Lansky (\<10).
- Adequate renal function (Serum Creatinine \</= 2.0 mg/dL). Pediatric: serum creatinine \</= 1.5 mg/dL or 2x upper limit of normal, for age.
- Patients will be stratified by liver function tests: Normal liver function: Total Bilirubin \</= 3 mg/dL, Alanine aminotransferase (ALT) \</= 5 times upper normal reference value. Abnormal liver function: Total bilirubin \>3 mg/dL and/or elevated ALT \> 5 x upper limit of normal (ULN). If bilirubin is \>/= 5 mg/dL, fluorouracil (5FU) dose will be omitted. Both of the above groups will be eligible.
- Adequate bone marrow function (Absolute Neutrophil Count (ANC) \>/=1500 cells/uL; Platelets (PLT) \>/= 100,000 cells/uL).
- At least three weeks from previous cytotoxic chemotherapy before day 1 of hepatic arterial infusion (HAI) infusion. After targeted or biologic therapy, there should be 5 half-lives or three weeks, whichever is shorter.
- All females in childbearing age MUST have a negative urine human chorionic gonadotropin (HCG) test 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 to sign informed consent form. Pediatric: age 7-18 would sign assent, (\<7 would not assent), parent or guardian would sign consent.
- Patients with colorectal cancer must agree to K-RAS mutational status screening, if not available. If tissue is not available, patients can enter on trial, but not on the cetuximab arms.
Exclusion
- Pregnant females.
- Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
- Serious or non-healing wound, ulcer or bone fracture.
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.
- Uncontrolled systemic vascular hypertension (Systolic blood pressure \> 140 mmHg, Diastolic Blood Pressure \> 90 mmHg).
- 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).
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00941499
Start Date
July 1 2009
End Date
May 1 2014
Last Update
November 18 2015
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030