Study of Chemotherapy With or Without Hepatic Arterial Infusion for Patients With Unresectable Metastatic Colorectal Cancer to the Liver

Conditions

• Colorectal Adenocarcinoma Metastatic to the Liver

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Floxuridine (FUDR) — DRUG
  5-Fluouracil (5FU) (1000 mg/m2/day continuous infusion over two days)
• Irinotecan (CPT-11) — DRUG
  Irinotecan (CPT) (150 mg/m2 IV over 30 min to an hour) on Day 1 and Day 15.
• FLUOROURACIL — DRUG
  5-Fluouracil (5FU) (1200 mg/m2/day continuous infusion over two days)
• PANITUMUMAB — DRUG
  Panitumumab (6 mg/kg IV over 60 min)
• DEXAMETHASONE — DRUG
  flat dose of 25 mg on Day 1
• Leucovorin — DRUG
  Leucovorin (LV) (400 mg/m2 IV over 30 min to an hour)

Study Details

The purpose of this study is to see if patients treated with both regional chemotherapy using the HAI pump and intravenous chemotherapy are able to have their liver tumors removed surgically (resected), versus treatment with only intravenous chemotherapy.

Key Dates

Start date

Feb 28, 2017

Status verified

May 2019

Primary completion

May 16, 2019

Completion

May 16, 2019

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: HAI FUDR/Dex in addition to Pmab plus FOLFIRI
  Panitumumab plus FOLFIRI on Day 1 and Day 15 of each cycle. HAI pump therapy with FUDR and Dex on Day 1 of each cycle. Patients will start protocol therapy approximately 2 weeks after surgery. All patients will receive Panitumumab (6 mg/kg IV over 60 min). The HAI FUDR group will receive FOLFIRI in the following dosing; 5-Fluouracil (5FU) (1000 mg/m2/day continuous infusion over two days), Leucovorin (LV) (400 mg/m2 IV over 30 min to an hour), and Irinotecan (CPT) (150 mg/m2 IV over 30 min to an hour) on Day 1 and Day 15.
• Experimental: Pmab plus FOLFIRI alone
  The dosing of FOLFIRI in the systemic arm will be 5-Fluouracil (5FU) (1200 mg/m2/day continuous infusion over two days), Leucovorin (LV) (400 mg/m2 IV over 30 min to an hour), bolus 5FU 400mg/ m2 and Irinotecan (CPT) (150 mg/m2 IV over 30 min to an hour) on Day 1 and 15.

Primary Outcome Measure

Resection rate assessed using RECIST (version 1.1) [ Time Frame: 3 months ]

Locations (5)

Find similar trials in Basking Ridge, NJ