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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 In Patients With Unresectable Hepatic Metastases From Colorectal Cancer


Phase 1
18 Years
N/A
Not 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 In Patients With Unresectable Hepatic Metastases From Colorectal Cancer


OBJECTIVES:

- Determine the maximum tolerated dose of oxaliplatin and fluorouracil when given with
leucovorin calcium and hepatic intra-arterial floxuridine and dexamethasone with or
without cryosurgery (group I cryosurgery closed to accrual as of 10/13/03) in patients
with unresectable liver metastases from colorectal cancer.

- Determine, preliminarily, the anti-tumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of oxaliplatin and fluorouracil. Patients are
assigned to one of two treatment groups. (Group I closed to accrual as of 10/13/03.)

- Group I (closed to accrual as of 10/13/03): Patients with no more than 8 hepatic
metastases and no metastases greater than 5 cm in diameter undergo cryosurgery prior to
chemotherapy. Chemotherapy is delayed for at least 4 weeks after cryosurgery.

- Group II: Patients with more than 8 hepatic metastases or at least one metastases
greater than 5 cm in diameter do not undergo cryosurgery prior to chemotherapy.

Beginning 2 weeks after pump placement surgery, all patients receive floxuridine and
dexamethasone by hepatic intra-arterial infusion continuously on days 1-14; oxaliplatin IV
over 2 hours and leucovorin calcium IV over 2 hours on days 15 and 29; and fluorouracil IV
continuously over 48 hours on days 15-16 and 29-30. Courses repeat every 36 days in the
absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin and fluorouracil until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 4-72 patients will be accrued for this study within 18
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the colon or rectum with unresectable
liver metastases that comprise less than 70% of liver parenchyma

- No extrahepatic disease

- No ascites

PATIENT CHARACTERISTICS:

Age:

- Over 18

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- No hepatic encephalopathy

Renal:

- Creatinine no greater than 1.5 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- No obstruction of gastrointestinal tract or genitourinary tract

- No symptomatic peripheral sensory neuropathy

- No active infection

- No other malignancy except resectable primary colorectal carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior floxuridine

- If undergoing cryosurgery (group I cryosurgery closed to accrual as of 10/13/03),
must have received one of the following:

- Systemic chemotherapy for metastatic disease

- Adjuvant therapy within the past 6 months comprising fluorouracil with or
without levamisole for resected primary colorectal carcinoma

- Adjuvant therapy within the past 12 months comprising fluorouracil and
leucovorin calcium with or without levamisole for resected primary colorectal
carcinoma

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to liver

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Nancy E. Kemeny, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

00-009

NCT ID:

NCT00008294

Start Date:

August 2000

Completion Date:

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021