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A Phase I Study Of Hepatic Arterial Infusion With Floxuridine And Dexamethasone In Combination With Intravenous Oxaliplatin Plus 5-Fluorouracil And Leucovorin As Adjuvant Treatment After Resection Of Hepatic Metastases From Colorectal Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Metastatic Cancer

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Trial Information

A Phase I Study Of Hepatic Arterial Infusion With Floxuridine And Dexamethasone In Combination With Intravenous Oxaliplatin Plus 5-Fluorouracil And Leucovorin As Adjuvant Treatment After Resection Of Hepatic Metastases From Colorectal Cancer


Subject

Inclusion Criteria:



- History of histologically confirmed colorectal adenocarcinoma metastatic to the liver
with no clinical or radiographic evidence of extrahepatic disease. Confirmation of
diagnosis must be performed at MSKCC.

- Potentially completely resectable hepatic metastases without current evidence of
other metastatic disease.

- Abdominal and pelvic CT scans and chest CT or x-ray within 6 weeks prior to
registration. (MRI of abdomen may be substituted for CT of abdomen.)

- Lab values within 14 days prior to registration:

- WBC ≥ 3.0 K/ul

- ANC >1.5 K/ul

- Platelets ≥ 100 K/ul

- Total bilirubin ≤ 1.5 mg/dl.

- Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration
to this study.

- KPS ≥ 60%

- Signed informed consent.

Subject Exclusion Criteria:

- Prior radiation to the liver. (Prior radiation therapy to the pelvis is acceptable if
completed at least 4 weeks prior to registration.)

- Active infection, ascites, hepatic encephalopathy

- Prior oxaliplatin or cisplatin or HAI FUDR

- Female patients who are pregnant or lactating

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Nancy E. Kemeny, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

03-005

NCT ID:

NCT00059930

Start Date:

January 2003

Completion Date:

June 2014

Related Keywords:

  • Colorectal Cancer
  • Metastatic Cancer
  • liver metastases
  • stage IV colon cancer
  • stage IV rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Liver Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903