Hepatic Arterial Infusion Oxaliplatin + 5FU, Leucovorin, and Bevacizumab +/- Cetuximab
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00941499
First received: July 15, 2009
Last updated: May 8, 2013
Last verified: May 2013
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Purpose
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 has spread to the liver. Different combinations of these drugs will be used, and the safety of all drug combinations will also be studied.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancers |
Drug: HAI Oxaliplatin Drug: 5-FU Drug: Bevacizumab Drug: Cetuximab Drug: Leucovorin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic Fluorouracil, Leucovorin and Bevacizumab With/Without Cetuximab by K-RAS Mutational Status and Liver Function for Advanced Cancers Metastatic to the Liver |
Resource links provided by NLM:
MedlinePlus related topics:
Cancer
Drug Information available for:
Fluorouracil
Leucovorin calcium
Oxaliplatin
Levoleucovorin
Cetuximab
Bevacizumab
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Dose and Toxicity [ Time Frame: Following each treatement cycle (every 3 weeks) ] [ Designated as safety issue: Yes ]
- Anti-Tumor Efficacy [ Time Frame: Following 2 cycles of therapy ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 198 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | July 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
HAI oxaliplatin in combination with HAI 5-fluorouracil and IV bevacizumab
|
Drug: HAI Oxaliplatin
140 mg/m^2 by HAI (hepatic arterial infusion)over 2 hours on Day 1 of each 21 day cycle
Other Name: Eloxatin
Drug: 5-FU
900-1750 mg/m^2 HAI infusion over 24 hours on Days 1 - 2 of each 21 day cycle.
Other Names:
Drug: Bevacizumab
10 mg/Kg by vein on Day 1 of 21 day cycle.
Other Names:
|
|
Experimental: Group 2
HAI oxaliplatin in combination with IV 5-fluorouracil, leucovorin, bevacizumab, and cetuximab
|
Drug: HAI Oxaliplatin
140 mg/m^2 by HAI (hepatic arterial infusion)over 2 hours on Day 1 of each 21 day cycle
Other Name: Eloxatin
Drug: Bevacizumab
10 mg/Kg by vein on Day 1 of 21 day cycle.
Other Names:
Drug: Leucovorin
200 mg/m^2 by vein on Days 1 and 2 of each 21 day cycle.
Other Names:
Drug: 5-FU
300-400 mg/m^2 bolus + 600-1000 mg/m^2 infusion over 22 hours on Days 1-2 of each cycle.
Other Names:
|
|
Experimental: Group 3
HAI oxaliplatin in combination with IV bevacizumab.
|
Drug: HAI Oxaliplatin
140 mg/m^2 by HAI (hepatic arterial infusion)over 2 hours on Day 1 of each 21 day cycle
Other Name: Eloxatin
Drug: Bevacizumab
10 mg/Kg by vein on Day 1 of 21 day cycle.
Other Names:
|
|
Experimental: Group 4
HAI oxaliplatin in combination with IV bevacizumab and cetuximab.
|
Drug: HAI Oxaliplatin
140 mg/m^2 by HAI (hepatic arterial infusion)over 2 hours on Day 1 of each 21 day cycle
Other Name: Eloxatin
Drug: Cetuximab
Loading dose of 250-500mg/m^2 and Maintenance dose of 125-250 mg/m^2 by vein on Day 1 of 21 day cycle.
Other Names:
Drug: Bevacizumab
7.5 - 15 mg/Kg by vein on Day 1 of 21 day cycle.
Other Names:
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941499
Contacts
| Contact: Apostolia M. Tsimberidou, MD, PHD | 713-792-4259 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Apostolia M. Tsimberidou, MD, PHD | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Apostolia M. Tsimberidou, MD, PHD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00941499 History of Changes |
| Other Study ID Numbers: | 2009-0023 |
| Study First Received: | July 15, 2009 |
| Last Updated: | May 8, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Advanced Cancers Liver Oxaliplatin Eloxatin Bevacizumab Avastin Anit-VEGF monoclonal antibody rhuMAb-VEGF 5-fluorouracil 5-FU |
Adrucil Efudex Leucovorin Citrovorum Wellcovorin Cetuximab C225 Erbitux IMC-C225 |
Additional relevant MeSH terms:
|
Neoplasms Antibodies Antibodies, Monoclonal Fluorouracil Oxaliplatin Bevacizumab Cetuximab Leucovorin Levoleucovorin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action |
Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Antidotes Protective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013