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

NCT ID: NCT00026234

Last Updated: 2013-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28

Brief Summary

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.

Detailed 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.

Conditions

Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum; Liver Metastases; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer; Stage IV Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (chemotherapy)

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.

Group Type: EXPERIMENTAL

floxuridine

Intervention Type: DRUG

Given intra-arterially

dexamethasone

Intervention Type: DRUG

Given intra-arterially

oxaliplatin

Intervention Type: DRUG

Given IV

capecitabine

Intervention Type: DRUG

Given orally

Interventions

floxuridine

Given intra-arterially

Intervention Type: DRUG

dexamethasone

Given intra-arterially

Intervention Type: DRUG

oxaliplatin

Given IV

Intervention Type: DRUG

capecitabine

Given orally

Intervention Type: DRUG

Other Intervention Names

5-FUDR; Aeroseb-Dex; Decaderm; Decadron; DM; DXM; 1-OHP; Dacotin; Dacplat; Eloxatin; L-OHP; CAPE; Ro 09-1978/000; Xeloda

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NSABP Foundation Inc

NETWORK

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Alberts

Role: PRINCIPAL_INVESTIGATOR

North Central Cancer Treatment Group

Locations

North Central Cancer Treatment Group

Rochester, Minnesota, United States

Countries

United States

References

Alberts SR, Roh MS, Mahoney MR, O'Connell MJ, Nagorney DM, Wagman L, Smyrk TC, Weiland TL, Lai LL, Schwarz RE, Molina R, Dentchev T, Bolton JS. Alternating systemic and hepatic artery infusion therapy for resected liver metastases from colorectal cancer: a North Central Cancer Treatment Group (NCCTG)/ National Surgical Adjuvant Breast and Bowel Project (NSABP) phase II intergroup trial, N9945/CI-66. J Clin Oncol. 2010 Feb 10;28(5):853-8. doi: 10.1200/JCO.2009.24.6728. Epub 2010 Jan 4.

Reference Type: DERIVED

PMID: 20048179 (View on PubMed)

Other Identifiers

N9945

Identifier Type: -

Identifier Source: secondary_id

CDR0000069011

Identifier Type: -

Identifier Source: secondary_id

NCCTG-N9945

Identifier Type: -

Identifier Source: secondary_id

NSABP-CI-66

Identifier Type: -

Identifier Source: secondary_id

U10CA025224

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2012-01866

Identifier Type: -

Identifier Source: org_study_id