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Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Oxaliplatin Plus Irinotecan in Patients With Unresectable Hepatic Metastases From Colorectal Cancer

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colon Cancer; Rectal Cancer

Intervention: Floxuridine, Oxaliplatin, CPT-11 (Drug); Floxuridine, Oxaliplatin, CPT-11 (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Nancy Kemeny, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

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.

Clinical Details

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

Primary outcome: 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.

Secondary outcome:

To determine the preliminary anti-tumor activity of the aforementioned combination chemotherapy.

To procure normal and disease liver tissue for evaluation of TS, p53, p21, TOPO 1, DPD, and ERCC levels.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States
Additional Information

Memorial Sloan-Kettering Cancer Center

Starting date: August 2000
Last updated: October 29, 2014

Page last updated: August 20, 2015

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