Hepatic Arterial Infusion Plus Chemotherapy in Treating Patients With Colorectal Cancer Metastatic to the Liver

National Cancer Institute (NCI)

Status and phase

Completed

Phase 2

Conditions

Stage IV Rectal Cancer

Recurrent Colon Cancer

Stage IV Colon Cancer

Adenocarcinoma of the Colon

Liver Metastases

Adenocarcinoma of the Rectum

Recurrent Rectal Cancer

Treatments

Drug: dexamethasone

Drug: oxaliplatin

Drug: capecitabine

Drug: floxuridine

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00026234

N9945

NCCTG-N9945

U10CA025224 (U.S. NIH Grant/Contract)

CDR0000069011

NCI-2012-01866

NSABP-CI-66

Details and patient eligibility

About

Phase II trial to study the effectiveness of hepatic arterial infusion plus chemotherapy in treating patients who have colorectal cancer metastatic to the liver. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different combinations and different ways may kill more tumor cells.

Full description

OBJECTIVES:

I. Determine the safety and toxicity of hepatic arterial infusion with floxuridine and dexamethasone followed by systemic therapy with oxaliplatin and capecitabine in patients with surgically resected liver metastases from primary colorectal carcinoma.

II. Determine the 2-year survival rate of patients treated with this regimen. III. Determine the 2-year recurrence rate and time to recurrence in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive floxuridine and dexamethasone intra-arterially continuously on days 1-14, oxaliplatin IV over 2 hours on day 22, and oral capecitabine twice daily on days 22-35. Treatment repeats every 6 weeks for 4 courses in the absence of disease recurrence or unacceptable toxicity. After completion of the fourth course, patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks for 2 courses in the absence of disease recurrence or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2.5 years.

PROJECTED ACCRUAL: A total of 15-75 patients will be accrued for this study within 9 months-3.25 years.

Enrollment

75 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Histologically confirmed colorectal adenocarcinoma metastatic to the liver
No extrahepatic metastases
Prior complete surgical resection of hepatic metastases (at least 1 lesion) within the past 21-56 days
- Negative surgical margins unless surrounding normal liver tissue was ablated during surgery
- Radiofrequency ablation may be used as adjunct to surgical resection but not as primary treatment
- No prior operative ultrasound during resection of hepatic metastases
Prior complete surgical resection of carcinoma of colon or rectum (must appear completely resectable in case of synchronous lesions)
Performance status - ECOG 0-1
Absolute neutrophil count at least 1,200/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than 1.5 times upper limit of normal (ULN)
AST no greater than 2.5 times ULN
Alkaline phosphatase no greater than 2.5 times ULN
No pre-existing chronic hepatic disease (chronic active hepatitis or cirrhosis)
Creatinine no greater than ULN
Creatinine clearance greater than 60 mL/min
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Adequate oral nutrition (at least 1,500 calories/day)
Able to withstand major operative procedure
No dehydration
No severe anorexia
No frequent nausea or vomiting
No prior or concurrent malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ
No prior or concurrent malignancy associated with more than 10% probability of death from malignant disease within 5 years of diagnosis
No concurrent immunotherapy
No concurrent colony-stimulating factors during the first course of study therapy
No more than 1 prior adjuvant systemic fluorouracil (5-FU) regimen with or without levamisole, leucovorin calcium, or irinotecan
- One prior 5-FU-based regimen as neoadjuvant treatment for rectal cancer is allowed
No prior hepatic artery infusion therapy with 5-FU or floxuridine
No prior systemic chemotherapy for metastatic disease
No other concurrent chemotherapy
No concurrent radiotherapy
See Disease Characteristics
No prior or concurrent sorivudine or brivudine