Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Liver Metastases From Colorectal Cancer
PHASE III STUDY OF HEPATIC ARTERY FLOXURIDINE (FUDR), LEUCOVORIN (LV), AND DEXAMETHASONE (DEX) VERSUS SYSTEMIC 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV) AS TREATMENT FOR HEPATIC METASTASES FROM COLORECTAL CANCER
NCT00002716CI-TRIAL-00022991completedPhase 3ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective for metastatic colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of intrahepatic floxuridine, leucovorin, and dexamethasone with that of systemic fluorouracil and leucovorin in treating patients who have 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 |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| floxuridine | Drug | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| laparotomy | Procedure | — | UNRESOLVED |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I - laparotomy + conventional surgery + chemotherapy
- description
- Patients undergo laparotomy for placement of a hepatic artery catheter and then subcutaneous placement of a hepatic artery infusion pump. Patients with unresected primary disease also undergo resection at the time of catheter and pump placement. Beginning within 1-2 weeks after surgery, patients receive floxuridine, dexamethasone, and leucovorin calcium (CF) via continuous hepatic artery infusion on days 1-14. Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months. Patients are followed every 3 months.
- interventionNames
- Drug: dexamethasone
- Drug: floxuridine
- Drug: leucovorin calcium
- Procedure: laparotomy
- Procedure: conventional surgery
- type
- EXPERIMENTAL
- label
- Arm II - conventional surgery + chemotherapy
- description
- Patients receive CF IV and fluorouracil IV on days 1-5. Patients with unresected primary disease undergo resection within 3-4 weeks before initiation of chemotherapy. Treatment for patients continues every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life and medical resource utilization are assessed at baseline, every 3 months for 1 year, and then at 18 months. Patients are followed every 3 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Unresectable liver metastases secondary to colorectal cancer
* Less than 70% liver involvement on CT scan or MRI
* Liver biopsy required before study unless 1 of the following conditions are met:
* Carcinoembryonic antigen greater than 30
* 5 or more liver metastases visible on CT scan or MRI
* Greater than 50% to under 70% liver involvement on CT scan or MRI
* Histologically proven primary colorectal cancer that is resected or appears resectable on CT scan and physical exam
* Documentation of previously resected primaries must be based on pathologic results of the resected tumor
* Histological documentation of synchronous disease must be based on 1 of the following:
* Biopsy of primary colorectal tumor before study
* Suspicious lesion on barium enema, colonoscopy, or sigmoidoscopy, and a liver biopsy positive for adenocarcinoma consistent with the primary colorectal tumor
* Measurable disease
* Clearly defined liver mass measuring at least 2 cm or at least 3 liver masses on CT scan or MRI
* No evidence of extrahepatic disease on CT scan and physical exam
* No portal vein occlusion or ascites
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Hepatic:
* Bilirubin no greater than 2 times normal
Other:
* No other malignancy within the past 5 years except inactive nonmelanomatous skin cancer, carcinoma in situ of the cervix, or grade 1 bladder cancer
* Not pregnant or nursing
* Fertile patients must use effective contraception
Chemotherapy:
* At least 1 year since prior adjuvant chemotherapy comprising fluorouracil (5-FU) and leucovorin calcium (CF) or 5-FU, CF, and levamisole (LEV)
* At least 6 months since prior adjuvant chemotherapy comprising 5-FU with or without LEV
* No other prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy except for nondisease-related conditions, e.g.:
* Steroids for adrenal failure
* Insulin for diabetes
* Intermittent dexamethasone as an antiemetic
Radiotherapy:
* No prior radiotherapy to the liverReferences
Publications (4)
- RESULTKemeny NE, Niedzwiecki D, Hollis DR, Lenz HJ, Warren RS, Naughton MJ, Weeks JC, Sigurdson ER, Herndon JE 2nd, Zhang C, Mayer RJ. Hepatic arterial infusion versus systemic therapy for hepatic metastases from colorectal cancer: a randomized trial of efficacy, quality of life, and molecular markers (CALGB 9481). J Clin Oncol. 2006 Mar 20;24(9):1395-403. doi: 10.1200/JCO.2005.03.8166. Epub 2006 Feb 27. PMID 16505413
- RESULTKemeny NE, Niedzwiecki D, Hollis DR, et al.: Final analysis of hepatic arterial infusion (HAI) versus systemic therapy for hepatic metastases from colorectal cancer: a CALGB randomized trial of efficacy, quality of life (QOL), cost effectiveness, and molecular markers. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-183, 2005.
- RESULTMandola MV, Stoehlmacher J, Muller-Weeks S, Cesarone G, Yu MC, Lenz HJ, Ladner RD. A novel single nucleotide polymorphism within the 5' tandem repeat polymorphism of the thymidylate synthase gene abolishes USF-1 binding and alters transcriptional activity. Cancer Res. 2003 Jun 1;63(11):2898-904. PMID 12782596
- RESULTPullarkat ST, Stoehlmacher J, Ghaderi V, Xiong YP, Ingles SA, Sherrod A, Warren R, Tsao-Wei D, Groshen S, Lenz HJ. Thymidylate synthase gene polymorphism determines response and toxicity of 5-FU chemotherapy. Pharmacogenomics J. 2001;1(1):65-70. doi: 10.1038/sj.tpj.6500012. PMID 11913730