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

NCT00695201 | Completed Phase 1

• 1 other identifier: 00-011
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Rectal Cancer

Keywords

DEXAMETHASONE; FLOXURIDINE; IRINOTECAN (CPT-11) CAMPTOSAR; OXALIPLATIN

Outcome Measures

Primary Outcomes (1)

• 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.

  conclusion of the study

Secondary Outcomes (2)

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

  conclusion of the study

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

  conclusion of the study

Study Arms (2)

1

EXPERIMENTAL

Patients will undergo pump placement and biopsy of diseased liver tissue. Chemotherapy will be initiated as soon as possible following verification of adequate pump placement and perfusion by radiographic pump study. Treatment will continue indefinitely unless a patient experiences a treatment endpoint.

Drug: Floxuridine, Oxaliplatin, CPT-11

2

EXPERIMENTAL

Patients will undergo pump placement and biopsy of diseased liver tissue. Chemotherapy will be initiated as soon as possible following verification of adequate pump placement and perfusion by radiographic pump study. Treatment will continue indefinitely unless a patient experiences a treatment endpoint.

Drug: Floxuridine, Oxaliplatin, CPT-11

Interventions

Floxuridine, Oxaliplatin, CPT-11 DRUG

For patients on the 4-week cycle: On the first day of each cycle, the pump will be filled with FUDR and dexamethasone. The pump will be emptied of drugs after 2 weeks (on day 15 of each cycle) and filled with heparin (which is used to prevent blood from clotting) and saline. Whether the pump contains drug or heparin and saline, it will need to be emptied and refilled about every two weeks. We will inject either the drugs or the saline and heparin into the pump through the skin using a needle and syringe. In summary, 2 weeks of drug in the pump is followed by 2 weeks without drug in the pump. The systemic chemotherapy (Oxaliplatin/CPT-11) will be administered on the same day as the pump is filled and emptied, ie. Day 1 and Day 15 of each cycle.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• University of Medicine and Dentistry of New Jersey: collaborator
• Rutgers, The State University of New Jersey: collaborator
• Sanofi: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Floxuridine; Oxaliplatin; Irinotecan

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Study Officials

• Nancy Kemeny, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 11, 2008
• Study Start: August 1, 2000
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: July 1, 2021

Record last verified: 2021-06

Locations

US (1)