Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combination With Chemotherapy With/Without Bevacizumab for Hepatic Metastases From Colorectal Cancer

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00200200
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab HAI plus systemic chemotherapy — DRUG
    Oxaliplatin (mg/m2) IV, over 2 hours, 5 FU (mg/m2) continuous infusion, over two days, leucovorin (mg/m2) IV, over 2 hours
  • HAI plus systemic chemotherapy — DRUG
    Irinotecan (mg/m2) IV, over 30 minutes, 5 FU (mg/m2) continuous infusion over two days, leucovorin (mg/m2) IV, over 30 minutes

Study Details

The purpose of this study is to determine whether the addition of bevacizumab, to hepatic arterial therapy with floxuridine (FUDR) and dexamethasone (Dex) (regional chemotherapy), and either oxaliplatin or CPT-11, plus 5-fluorouracil and leucovorin (systemic chemotherapy) will increase disease free survival in patients who have undergone liver resection. The patient will be randomized (a computer generated decision as in the flip of a coin) to receive, or not to receive bevacizumab in addition to regional and systemic chemotherapy.

Key Dates

First listed
Sep 20, 2005
Start date
Nov 19, 2004
Status verified
Mar 2025
Primary completion
Mar 13, 2025
Completion
Mar 13, 2025

Study Design

Enrollment
73 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Bevacizumab in addition to HAI plus systemic chemotherapy
  • Experimental: 2
    HAI plus systemic chemotherapy alone

Primary Outcome Measure

To determine whether the addition of concurrent intravenous bevacizumab to HAI plus systemic chemotherapy increases the time to progression in patients with completely resected hepatic metastases from colorectal cancer [ Time Frame: 7.5 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Follow Up Only)Basking RidgeNew Jersey--
Memorial Sloan Kettering Cancer Commack (Follow Up Only)CommackNew York11725-
Memorial Sloan Kettering Westchester (Follow Up Only)HarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering Nassau (Follow Up Only)UniondaleNew York11553-

Find similar trials in Basking Ridge, NJ

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Memorial Sloan Kettering Basking Ridge (Follow Up Only)· Basking Ridge, NJMemorial Sloan Kettering Cancer Commack (Follow Up Only)· Commack, NYMemorial Sloan Kettering Westchester (Follow Up Only)· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NYMemorial Sloan Kettering Nassau (Follow Up Only)· Uniondale, NY

Related Studies