Clinical trial · Interventional
Paclitaxel Administered by HAI to Patients With Advanced Cancer and Dominant Liver Involvement
Phase I Study of Paclitaxel Administered by Hepatic Artery Infusion to Patients With Advanced Cancer and Dominant Liver Involvement
NCT00508326CI-TRIAL-00007585completedPhase 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 find the highest tolerated dose of paclitaxel that can be given directly into the liver of patients with advanced cancer involving the liver. Researchers also want to collect descriptive information on any effects the drug may have on tumor tissue.
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 Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HAI Paclitaxel
- description
- Paclitaxel via Hepatic Artery Infusion (HAI)
- interventionNames
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Maximum Tolerated Dose of Monthly Cytotoxic Intraarterial Hepatic Paclitaxel
- timeFrame
- Monthly
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 13 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically confirmed diagnosis of advanced malignancy and liver involvement as dominant site of metastasis. 2. Performance status ECOG \< or = 2 (Requires occasional assistance but is able to care for own needs). 3. Adequate renal function (serum creatinine \< 2.0 mg/dL). 4. Adequate hepatic function (Total bilirubin \< 2.0 mg/dL; ALT \</= 5 times upper normal reference value). 5. Bone marrow function (ANC \>or =1.5 cells/mcL; PLT \> or = 100,000 cells/mcL). 6. At least three weeks from previous therapy and complete recovery from all associated acute toxicities. 7. Ability to fully read, comprehend, and sign informed consent forms. 8. All females in childbearing age must have a negative urine or serum HCG test unless prior hysterectomy or menopause. Women of childbearing potential and men must use effective birth control. 9. Patients should be refractory to standard chemotherapy or have no conventional therapy that produces a CR rate of at least 10% or an increase in survival of at least three months. 10. Patients of both genders, 13 year-old or older. Exclusion Criteria: 1. Clinical or radiographic evidence of ascites. 2. Pregnant or breastfeeding females. 3. Hypersensitivity to paclitaxel compounds. 4. History of severe hypersensitivity reactions to products containing polyoxyethylated castor oil or Cremophor. 5. Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements. 6. Untreatable bleeding diathesis. 7. Portal vein thrombosis. 8. Peripheral neuropathy \> Grade 1 according to NCI CTC v.3.0: sensory alteration not interfering with function). 9. Untreated (radiation therapy, chemotherapy, surgery or a combination of modalities) brain metastasis.
References
Publications (0)
Data not yet available
No reference posted for this study.