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A Phase II Trial Evaluating Multiple Metastasectomy Combined With Hepatic Artery Infusion Of Floxuridine (FUDR) And Dexamethasone (DXM), Alternating With Systemic Oxaliplatin (OXAL) And Capecitabine (CAPCIT) For Colorectal Carcinoma Metastatic To The Liver


Phase 2
N/A
N/A
Not Enrolling
Both
Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Liver Metastases, Recurrent Colon Cancer, Recurrent Rectal Cancer, Stage IV Colon Cancer, Stage IV Rectal Cancer

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Trial Information

A Phase II Trial Evaluating Multiple Metastasectomy Combined With Hepatic Artery Infusion Of Floxuridine (FUDR) And Dexamethasone (DXM), Alternating With Systemic Oxaliplatin (OXAL) And Capecitabine (CAPCIT) For Colorectal Carcinoma Metastatic To The Liver


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity of oxaliplatin as assessed by the National Cancer Institute (NCI) Common Terminology Criteria (CTC) version 2.0

Outcome Time Frame:

Up to 6 months

Safety Issue:

Yes

Principal Investigator

Steven Alberts

Investigator Role:

Principal Investigator

Investigator Affiliation:

North Central Cancer Treatment Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01866

NCT ID:

NCT00026234

Start Date:

February 2002

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • Liver Metastases
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms

Name

Location

North Central Cancer Treatment GroupRochester, Minnesota  55905