Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab

NCT01213238 | Completed Phase 1 FDA Drug

• 2 other identifiers: 2010-0413NCI-2012-01901
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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 advanced cancer that has spread to the liver. The safety of these drug combinations will also be studied.

Conditions

Advanced Cancers

Keywords

Liver metastasis; hepatic arterial infusion; HAI; Eloxatin; Xeloda; Avastin; Anti-VEGF monoclonal antibody; rhuMAb-VEGF; Oxaliplatin; Capecitabine; Bevacizumab

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Hepatic Arterial IUnfusion (HAI) Oxaliplatin, with Oral Capecitabine, with or without Systemic Intravenous Bevacizumab

  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.

  First 21 day cycle

Study Arms (2)

Oxaliplatin + Capecitabine + Bevacizumab

EXPERIMENTAL

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; Drug: Capecitabine; Drug: Bevacizumab

Oxaliplatin + Capecitabine

EXPERIMENTAL

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; Drug: Capecitabine

Interventions

Oxaliplatin DRUG

140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle.

Also known as: Eloxatin

Oxaliplatin + Capecitabine; Oxaliplatin + Capecitabine + Bevacizumab

Capecitabine DRUG

Starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle.

Also known as: Xeloda

Oxaliplatin + Capecitabine; Oxaliplatin + Capecitabine + Bevacizumab

Bevacizumab DRUG

10 mg/kg by vein on day 1 of a 21 day cycle.

Also known as: Avastin, Anti-VEGF monoclonal antibody, rhuMAb-VEGF

Oxaliplatin + Capecitabine + Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Oxaliplatin; Capecitabine; Bevacizumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Apostolia M. Tsimberidou, MD, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 1, 2010
• Study Start: September 30, 2010
• Primary Completion: September 26, 2018
• Study Completion: September 26, 2018
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

US (1)