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Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, Leucovorin, and Avastin
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, August 2008
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00507585
  Purpose

PRIMARY

- To determine the toxicity and tolerability of intra-arterial hepatic oxaliplatin every three weeks administered in combination with systemic intravenous Fluorouracil, Leucovorin and bevacizumab to patients with advanced solid tumors metastatic to the liver.

SECONDARY

  • To document in a descriptive fashion the antitumor efficacy of this combination regimen.
  • To evaluate the feasibility and accuracy of an alternate radiographic assessment tool and compare with available tumor markers and RECIST guidelines.
  • To estimate in a descriptive fashion the development of extrahepatic tumor recurrences.

Condition Intervention Phase
Liver Cancer
Drug: Fluorouracil
Drug: Avastin
Drug: Leucovorin
Drug: Oxaliplatin
Phase I

MedlinePlus related topics: Cancer Liver Cancer
Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Bevacizumab Fluorouracil Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase I Study of Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic Fluorouracil, Leucovorin and Avastin for Patients With Advanced Solid Tumors Metastatic to the Liver

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • The goal of this clinical research study is to find the highest tolerable dose of oxaliplatin used in combination with 5-fluorouracil, leucovorin, and Avastin® (bevacizumab) for patients with advanced cancer that has spread to the liver. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety and effectiveness of this study drug combination will also be studied. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 81
Study Start Date: June 2006
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Oxaliplatin + Fluorouracil + Leucovorin + Avastin
Drug: Fluorouracil
300 mg/m^2 IV Over 10 Minutes, then 600 mg/m^2 IV Over 22 Hours
Drug: Avastin
10 mg/m^2 IV Over 90 Minutes
Drug: Leucovorin
200 mg/m^2 IV Over 2 Hours
Drug: Oxaliplatin
60 mg/m^2 IV Over 2 Hours

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  1. Patients with histologically confirmed metastatic advanced solid tumors involving the liver.
  2. Pediatric patients eligible at the discretion of the primary investigator.
  3. Performance status ECOG 0-2 (Capable of all self care but unable to to carry out any work activities).
  4. Adequate renal function (Serum Creatinine </= 2.0 mg/dL) or a calculated creatinine clearance greater than 60 mL/min.
  5. Hepatic function as follows: In treatment arm 1: Total Bilirubin </= 3 mg/dL, AST </= 5 times upper normal reference value, or ALT </= 5 times upper normal reference value). In treatment arm 2: Total bilirubin >3 mg/dL. If bilirubin >/= 5 mg/dL, fluorouracil (5FU) dose will be omitted.
  6. Adequate bone marrow function (ANC >/=1500 cells/uL; PLT >/= 100,000 cells/uL).
  7. At least three weeks from previous immunotherapy, chemotherapy or radiotherapy before day of HAI infusion and recovery from any associated toxicities to less or equal to Grade 1.
  8. All females in childbearing age MUST have a negative serum 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.
  9. Ability to fully read, comprehend, and sign informed consent forms.

Exclusion:

  1. Clinical or radiographic evidence of ascites.
  2. Pregnant females.
  3. Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements.
  4. Grade 2 Peripheral Neuropathy (CTC V3.0: Sensory alteration interfering with function but not interfering with ADL)
  5. Serious or non-healing wound, ulcer or bone fracture.
  6. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days.
  7. Invasive procedures defined as follows; Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 1 therapy, Anticipation of need for major surgical procedures during the course of the study, Core biopsy within 7 days prior to D1 of therapy.
  8. Patients receiving any other investigational agents.
  9. Patients with bleeding diathesis (clinical bleeding, prothrombin time =/> 1.5 X upper institutional normal value, INR =/> 1.5, activated partial thromboplastin time aPTT =/> 1.5 X upper institutional normal value), active gastric or duodenal ulcer.
  10. Uncontrolled systemic vascular hypertension (Systolic blood pressure > 140 mmHg, Diastolic Blood Pressure > 90 mmHg).
  11. Urine protein should be screened by dipstick or urine analysis. For proteinuria > 1+ or urine protein:creatinine ratio > 1.0, a 24-hour urine protein should be obtained and the level should be < 1000 mg for patient enrollment.
  12. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  13. Patients with clinically significant cardiovascular disease: History of CVA within 6 months, myocardial infarction or unstable angina within 6 months, New York Heart Association Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris, clinically significant peripheral vascular disease
  14. Patients with history of bleeding CNS metastasis will be excluded from the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00507585

Contacts
Contact: Apostolia M. Tsimberidou, MD, PhD 713-792-4259
Contact: Dwana Sanders 713-794-1290

Locations
United States, Texas
U.T.M.D. 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
Principal Investigator: Apostolia M. Tsimberidou, MD, PhD U.T.M.D. Anderson Cancer Center
  More Information

MD Anderson Cancer Center website  This link exits the ClinicalTrials.gov site

Responsible Party: U.T.M.D. Anderson Cancer Center ( Apostolia M. Tsimberidou, MD, PhD/Assistant Professor )
Study ID Numbers: 2006-0160
Study First Received: July 24, 2007
Last Updated: August 26, 2008
ClinicalTrials.gov Identifier: NCT00507585  
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Liver Cancer
Hepatic Arterial Infusion
Fluorouracil
Avastin
Leucovorin
Oxaliplatin
Bevacizumab

Study placed in the following topic categories:
Liver Neoplasms
Oxaliplatin
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Fluorouracil
Liver neoplasms
Leucovorin
Gastrointestinal Neoplasms
Bevacizumab

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Growth Inhibitors
Angiogenesis Modulating Agents
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009