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A Phase I Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer.


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Colon Cancer, Rectal 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 Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer.


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.

- Patient's liver metastases must be deemed unresectable and comprise <70% of the liver
parenchyma.

- A patient may have had prior chemotherapy or be previously untreated.

- Patient may not have received prior treatment with FUDR or >2 doses of Oxaliplatin.

- KPS > or = to 60%.

- WBC > or = to 3,000 cells/mm3 and platelet count > or = to 100,000 cells/mm3 within
14 days of registration.

- Creatinine < or = to 1.5 mg/dl within 14 days of registration.

- Total serum bilirubin < or = 2.0 mg/dl within 14 days of registration.

Exclusion Criteria:

- No active concurrent malignancies: except a patient's potentially resectable
colorectal primary.

- Patient must not have obstruction of GI or GU tract.

- Patient must not have current, symptomatic peripheral sensory neuropathy.

- No prior radiation to liver.

- No active infection, ascites, or hepatic encephalopathy.

- Age ≥ 18 years.

- Female patients cannot be pregnant or lactating.

- Signed informed consent.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine the MTD of hepatic arterial floxuridine (FUDR) & dexamethasone (Dex) given via implanted pump in combination w biweekly intravenous Oxaliplatin + systemic irinotecan (CPT-11) in patients w unresectable hepatic metastases from colorectal cancer.

Outcome Time Frame:

conclusion of the study

Safety Issue:

Yes

Principal Investigator

Nancy Kemeny, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

00-011

NCT ID:

NCT00695201

Start Date:

August 2000

Completion Date:

August 2013

Related Keywords:

  • Colon Cancer
  • Rectal Cancer
  • DEXAMETHASONE
  • FLOXURIDINE
  • IRINOTECAN (CPT-11) CAMPTOSAR
  • OXALIPLATIN
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021