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



Status:Recruiting
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:5/19/2018
Start Date:February 28, 2017
End Date:February 2020
Contact:Andrea Cercek, MD
Email:cerceka@mskcc.org
Phone:646-888-4189

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A Randomized, Multicenter Phase II Study of Panitumumab Plus FOLFIRI With or Without Hepatic Arterial Infusion as Second-Line Treatment in Patients With Wild Type RAS Who Have Unresectable Hepatic Metastases From Colorectal Cancer

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.


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 by the enrolling institution.

- Patients must have a primary L sided colorectal cancer, (at or distal to the splenic
flexure)

- Confirmed RAS/RAF wild type tumor. Paraffin-embedded tumor tissue obtained from the
primary tumor or metastasis

- Have received prior treatment for metastatic disease with oxaliplatin-based regimen
and either

- Had disease progression OR

- Had stable disease OR

- Discontinued oxaliplatin due to neuropathy

- Patients must meet the following criteria for unresectability as determined by two
hepatobiliary surgeons and one radiologist:

- When a margin negative resection would require resection of all three hepatic
veins, both portal veins, or the retrohepatic vena cava.

- Requiring a resection that leaves less than 2 hepatic segments (not including the
caudate lobe) behind with adequate arterial/portal inflow, venous outflow and
biliary drainage. **

**A patient is considered resectable if the procedure includes a minor wedge or
thermo-ablation encompassing 10% or less of the volume of the remaining 2
segments.

- Patient‟s liver metastases must comprise <70% of the liver parenchyma. All
patients must be clinically fit to undergo surgery as determined by the
pre-operative evaluation

- Lab values within 14 days prior to enrollment/randomization:

- WBC ≥ 3.0 K/uL

- ANC > 1.5 K/uL

- Platelets ≥ 100,000/uL

- Renal function (≤ 10 days prior to enrollment/randomization) °Creatinine ≤ 1.5 mg/dL
or creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault method as
follows:

Cockcroft-Gault method as follows:

- Male creatinine clearance = (140 -age in years) x (weight in Kg) / (serum Cr in mg/dl
x 72)

- Female creatinine clearance = (140 - age in years) x (weight in Kg) x 0.85 / (serum Cr
in mg/dl x 72) (use of creatinine clearance per protocol based on chemotherapy
regimen)

- Hepatic function, as follows: (≤ 10 days prior to enrollment/randomization)

- Total Bilirubin ≤ 1.5 mg/dl

- Calcium ≥ lower limit of normal (≤ 48 hours prior to enrollment/randomization)

- KPS ≥ 60% (ECOG (or Karnofsky) performance status (preferably 0 or 1/≥ 60% for
Karnofsky))

Exclusion Criteria:

- Patients < 18 years of age

- Patients who have received more than one chemotherapy regimen for metastatic disease

- Patients who are chemotherapy naïve

- Prior radiation to the liver (Prior radiation therapy to the pelvis is acceptable if
completed at least 4 weeks prior to registration)

- Active infection

°Active infection includes patients with positive blood cultures

- Prior treatment with HAI FUDR

- Prior TACE

- Female patients who are pregnant or lactating - or planning to become pregnant within
6 months after the end of the treatment (female patients of child-bearing potential
must have negative pregnancy test ≤ 72 hours before enrollment and randomization, and
must have a negative pregnancy test ≤ 72 hours prior to treatment start)

- If a patient has any serious medical problems which may preclude receiving this type
of treatment

- Patients with history or known presence of primary CNS tumors, seizures not
well-controlled with standard medical therapy, or history of stroke will also be
excluded.

- Serious or non-healing active wound, ulcer, or bone fracture

- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease on baseline chest CT scan

- Patients who have a diagnosis of Gilbert‟s disease

- History of other malignancy, except:

1. Malignancy treated with curative intent and with no known active disease present
for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by
the treating physician

2. Adequately treated non-melanomatous skin cancer or lentigo maligna without
evidence of disease

3. Adequately treated cervical carcinoma in situ without evidence of disease
We found this trial at
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sites
Basking Ridge, New Jersey 07920
Principal Investigator: Andrea Cercek, MD
Phone: 646-888-4189
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Commack, New York 11725
Principal Investigator: Andera Cercek, MD
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Harrison, New York
Phone: 646-888-4189
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Middletown, New Jersey 07748
Phone: 646-888-4189
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Andrea Cercek, MD
Phone: 646-888-4189
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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