Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01213238
First received: September 30, 2010
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Advanced Cancers
Drug: Oxaliplatin
Drug: Capecitabine
Drug: Bevacizumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial of Hepatic Arterial Infusion of Oxaliplatin, Oral Capecitabine, With or Without Systemic Bevacizumab for Patients With Advanced Cancer Metastatic to the Liver

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of Hepatic Arterial IUnfusion (HAI) Oxaliplatin, with Oral Capecitabine, with or without Systemic Intravenous Bevacizumab [ Time Frame: First 21 day cycle ] [ Designated as safety issue: Yes ]
    If more than 33% of patients enrolled in any particular dose level develop dose limiting toxicity (DLT), treatment will continue at dose level immediately below. If not more than 33% of the patients in cohort develop DLT, this cohort considered MTD. DLT defined as any grade 3 or 4 non-hematologic toxicity as defined in current version of NCI CTCAE, even if related to study medications (except nausea and vomiting, electrolyte imbalances responsive to appropriate regimens or alopecia), any grade 4 nausea or vomiting > 5 days despite maximum anti-nausea regimens, and any other grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome, but excluding alopecia; grade 4 thrombocytopenia; any grade 4 neutropenia of more than seven days duration, despite supportive care or associated with bleeding and/or sepsis; or any severe or life-threatening complication or abnormality not covered in NCI CTCAE. MTD defined by DLTs that occur in first cycle.


Estimated Enrollment: 116
Study Start Date: September 2010
Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxaliplatin + Capecitabine + Bevacizumab
Oxaliplatin 140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle. Capecitabine starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle. Bevacizumab 10 mg/kg by vein on day 1 of a 21 day cycle.
Drug: Oxaliplatin
140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle.
Other Name: Eloxatin
Drug: Capecitabine
Starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle.
Other Name: Xeloda
Drug: Bevacizumab
10 mg/kg by vein on day 1 of a 21 day cycle.
Other Names:
  • Avastin
  • Anti-VEGF monoclonal antibody
  • rhuMAb-VEGF
Experimental: Oxaliplatin + Capecitabine
Oxaliplatin 140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle. Capecitabine starting dose of 500 mg/m2 by mouth twice daily, on days 1 -14 of a 21 day cycle.
Drug: Oxaliplatin
140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle.
Other Name: Eloxatin
Drug: Capecitabine
Starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle.
Other Name: Xeloda

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 </= 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.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213238

Contacts
Contact: Apostolia M. Tsimberidou, MD, PHD 713-792-4259

Locations
United States, Texas
University of Texas 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
Principal Investigator: Apostolia M. Tsimberidou, MD, PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01213238     History of Changes
Other Study ID Numbers: 2010-0413, NCI-2012-01901
Study First Received: September 30, 2010
Last Updated: September 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Liver metastasis
hepatic arterial infusion
HAI
Eloxatin
Xeloda
Avastin
Anti-VEGF monoclonal antibody
rhuMAb-VEGF
Oxaliplatin
Capecitabine
Bevacizumab

Additional relevant MeSH terms:
Neoplasms
Antibodies, Monoclonal
Bevacizumab
Capecitabine
Fluorouracil
Oxaliplatin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014