Clinical trial · Interventional
Cisplatin HAI Study in Patients With Advanced Cancer and Dominant Liver Involvement
A Phase I Study Dose Escalation Clinical Study Of Hepatic Intraarterial Cisplatin, In Combination With Systemic Intravenous Liposomal Doxorubicin Administered Every Four Weeks to Patients With Advanced Cancer And Dominant Liver Involvement
- 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 safe dose of cisplatin that can be given with liposomal doxorubicin in the treatment of advanced cancer involving the liver. PRIMARY Objectives: To determine the toxicity and safety of a monthly cytotoxic regimen combining intraarterial hepatic (HAI) cisplatin with systemic intravenous liposomal doxorubicin in patients with cancer metastatic to the liver. SECONDARY Objectives: To document in a descriptive fashion the antitumor efficacy of monthly hepatic intraarterial cisplatin in combination with systemic liposomal doxorubicin.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Liposomal Doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cisplatin + Liposomal Doxorubicin
- description
- Cisplatin 100 mg/m\^2 Intraarterial and Liposomal Doxorubicin starting dose 20 mg/m\^2 by vein on Day 1 every 4 weeks
- interventionNames
- Drug: Cisplatin
- Drug: Liposomal Doxorubicin
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- With each 4 week cycle (28 days)
- description
- Dose level at which no dose limiting toxicities are seen for a monthly cytotoxic regimen combining intraarterial hepatic cisplatin with systemic intravenous liposomal doxorubicin.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with Histologically confirmed diagnosis of malignancy and liver involvement as dominant site of metastasis (over 50% of all tumor burden). 2. Pediatric patients eligible at the discretion of the primary investigator. 3. Performance Status Equivalent or Grater than 60% in the Karnofsky's Performance scale (Requires occasional assistance but is able to care for own needs). 4. Adequate Renal Function (Serum CRE \</= 1.5 mg/dL) or calculated Creatinine Clearance \>/= 50 ml/min (Cockcroft Formula). 5. Adequate Hepatic Function (Total Bilirubin \</= 1.5 mg/dL or ALT \</= 5 times upper normal reference value). 6. Adequate Bone Marrow Function (Absolute neutrophil count (ANC) \>/= 1.5 cells/uL; number of platelets (PLT) \>/= 100,000 cells/uL). 7. At least three weeks from previous cytotoxic chemotherapy before day 1 of HAI infusion. After targeted or biologic therapy there should be 5 half-lives or three weeks, whichever is shorter. 8. All Females in Childbearing Age MUST have a negative urine or serum Human chorionic gonadotropin or human chorionic gonadotrophin (hCG) test unless prior hysterectomy or menopause (defined as age above 55 and six months without menstrual activity). 9. Ability to fully read, comprehend, and sign informed consent forms. In pediatric patients, the informed consent forms will be signed by a parent or legal guardian. 10. Patients with germ cell tumors and lymphoma MUST have had documented progression of disease prior to enrollment. Exclusion Criteria: 1. Clinical or radiographic evidence of Ascites. 2. Pregnant females. 3. Hypersensitivity to platinum compounds or anthracyclines. 4. Inability to complete informed consent process and adhere to protocol treatment plan and follow-up requirements. 5. Jaundice. (Bilirubin \> 1.5 mg/dL). 6. Bleeding Diathesis.(Prothrombin time \> 20 secs or International Normalized Ratio (INR) \> 2.0). 7. Portal vein thrombosis. 8. Grade 2 Peripheral Neuropathy (CTC V3.0: Sensory alteration interfering with function but not interfering with ADL) 9. Medical History or Clinical Evidence of Congestive Heart Failure.
References
Publications (0)
Data not yet available