Combination Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver

Sponsor

UNICANCER (Other)

Overall Status

Completed

CT.gov ID

NCT00006050

Collaborator

(none)

Locations

Actual Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of liver perfusion using oxaliplatin plus leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer that has spread to the liver.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Metastatic Cancer	Drug: FOLFOX regimen Drug: fluorouracil Drug: isolated perfusion Drug: leucovorin calcium Drug: oxaliplatin	Phase 2

Detailed Description

OBJECTIVES: I. Determine the efficacy and tolerance of oxaliplatin by hepatic perfusion combined with intravenous leucovorin calcium and fluorouracil in patients with liver metastases from colorectal cancer.

OUTLINE: Patients receive oxaliplatin by hepatic perfusion over 2 hours on day 1 plus leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. If a good response is achieved after 8 courses of chemotherapy, patients may undergo surgical resection of metastases.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

Chemotherapy Intra-Arterial Hepatic With Oxaliplatin Combined With Leucovorin Calcium and Fluorouracil IV

Actual Study Start Date :

Apr 4, 1999

Actual Primary Completion Date :

Dec 31, 2001

Actual Study Completion Date :

Apr 4, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically proven colorectal cancer metastatic to the liver Unresectable disease Less than 50% invasion of the liver Measurable disease No prior irradiation Largest diameter at least 20 mm No detectable extrahepatic disease

PATIENT CHARACTERISTICS: Age: Under 75 Performance status: WHO 0-2 Life expectancy: Greater than 2 months Hematopoietic: WBC at least 4,000/mm3 Neutrophil count at least 1,500/mm3

Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 35 micromoles/L Renal:

Creatinine less than 130 micromoles/L Cardiovascular: No severe cardiac insufficiency Pulmonary: No respiratory disease that would preclude study Other: No other serious illness that would preclude study No psychological illness that would preclude study No peripheral neuropathy No prior malignancy not considered cured Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior intravenous oxaliplatin No more than 1 prior regimen of intravenous chemotherapy for metastatic disease Primary chemotherapy of fluorouracil allowed if stable or progressive disease No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Institut J. Paoli and I. Calmettes	Marseille	France	13273
2	Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle	Montpellier	France	34298
3	Institut Gustave Roussy	Villejuif	France	F-94805