Clinical trial NCT00695201: Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colon Cancer
Rectal Cancer
Keywords: DEXAMETHASONE
FLOXURIDINE
IRINOTECAN (CPT-11) CAMPTOSAR
OXALIPLATIN
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Medicine and Dentistry of New Jersey
name: Rutgers, The State University of New Jersey
name: Sanofi
First posted: 2008-06-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see how well patients tolerate the side effects of treatment with Floxuridine, Oxaliplatin and Irinotecan. We also want to know if these methods used together are a useful way of treating cancer. We have studied these drugs and know the best doses of each when they are used alone. We do not yet know how well the drugs work with each other. This study will tell us the best doses of each drug when they are given over the same period of time.


Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: conclusion of the study
Secondary outcomes:
measure: To determine the preliminary anti-tumor activity of the aforementioned combination chemotherapy.
timeFrame: conclusion of the study
measure: To procure normal and disease liver tissue for evaluation of TS, p53, p21, TOPO 1, DPD, and ERCC levels.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Nancy Kemeny, MD
role: PRINCIPAL_INVESTIGATOR
References: