Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Unresectable Liver Metastases From Colorectal Cancer
A Phase I Study Of Hepatic Arterial Infusion With Floxuridine And Dexamethasone In Combination With Intravenous Oxaliplatin Plus 5-Fluorouracil And Leucovorin In Patients With Unresectable Hepatic Metastases From Colorectal Cancer
- 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Cryosurgery kills cancer cells by freezing them. Combining more than one chemotherapy drug with cryosurgery and giving drugs in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of intrahepatic and intravenous combination chemotherapy with or without cryosurgery in treating unresectable liver metastases from colorectal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dexamethasone | Drug | Dexamethasone | ALIAS |
| floxuridine | Drug | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| FOLFOX regimen | Drug | FOLFOX Regimen | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum with unresectable liver metastases that comprise less than 70% of liver parenchyma * No extrahepatic disease * No ascites PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * No hepatic encephalopathy Renal: * Creatinine no greater than 1.5 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * No obstruction of gastrointestinal tract or genitourinary tract * No symptomatic peripheral sensory neuropathy * No active infection * No other malignancy except resectable primary colorectal carcinoma PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior floxuridine * If undergoing cryosurgery (group I cryosurgery closed to accrual as of 10/13/03), must have received one of the following: * Systemic chemotherapy for metastatic disease * Adjuvant therapy within the past 6 months comprising fluorouracil with or without levamisole for resected primary colorectal carcinoma * Adjuvant therapy within the past 12 months comprising fluorouracil and leucovorin calcium with or without levamisole for resected primary colorectal carcinoma Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to liver Surgery: * Not specified
References
Publications (2)
- RESULTKemeny N, Capanu M, D'Angelica M, Jarnagin W, Haviland D, Dematteo R, Fong Y. Phase I trial of adjuvant hepatic arterial infusion (HAI) with floxuridine (FUDR) and dexamethasone plus systemic oxaliplatin, 5-fluorouracil and leucovorin in patients with resected liver metastases from colorectal cancer. Ann Oncol. 2009 Jul;20(7):1236-41. doi: 10.1093/annonc/mdn769. Epub 2009 Feb 20. PMID 19233901
- RESULTKemeny N, Jarnagin W, Paty P, Gonen M, Schwartz L, Morse M, Leonard G, D'Angelica M, DeMatteo R, Blumgart L, Fong Y. Phase I trial of systemic oxaliplatin combination chemotherapy with hepatic arterial infusion in patients with unresectable liver metastases from colorectal cancer. J Clin Oncol. 2005 Aug 1;23(22):4888-96. doi: 10.1200/JCO.2005.07.100. Epub 2005 Jul 11. PMID 16009951