Clinical trial · Interventional
Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab
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
NCT01213238CI-TRIAL-00037628completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Oxaliplatin + Capecitabine + Bevacizumab
- description
- 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.
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- Oxaliplatin + Capecitabine
- description
- 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.
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.