The purpose of this study is to see if Panitumumab plus the other treatments will increase
the time of remission. Remission means that there is no sign of the cancer.
Drug: Randomization to No Panitumumab
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01312857
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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.
Completely resected hepatic metastases without current evidence of other metastatic
Lab values ≤ 14 days prior to treatment start:
WBC ≥ 3.0 K/uL
ANC > 1.5 K/uL
Platelets ≥ 100,000/uL
Creatinine <1.5 mg/dL
HGB ≥ 9 gm/dL Renal function (≤ 14 days prior to treatment start).
Creatinine ≤1.5 mg/dL or creatinine clearance ≥ 50 mL/min calculated by the
Cockcroft-Gault method as follows:
Male creatinine clearance = (140 -age in years) x (weight in Kg) / (serum Cr in mg/dl
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: (≤ 14 days prior to treatment start)
Aspartate aminotransferase (AST) (≤ 5 x ULN)
Alanine aminotransferase (ALT) (≤ 5 x ULN)
Total Bilirubin ≤ 1.5 mg/dl
Magnesium ≥ lower limit of normal (≤ 48 hours prior to treatment start.)
Calcium ≥ lower limit of normal (≤ 48 hours prior to treatment start.)
Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration to
this study. [Note: no chemotherapy to be given after resection of liver lesions prior
to treatment on this study.]
Any investigational agent is acceptable if administered ≤ 30 days before registration
KPS ≥ 60% (ECOG (or Karnofsky) performance status (preferably 0 or 1/≥ 60% for
Histologically confirmed all RAS wild type.
Paraffin-embedded tumor tissue obtained from the primary tumor or metastasis (Prior to
Patients < 18 years of age.
Prior radiation to the liver (Prior radiation therapy to the pelvis is acceptable if
completed at least 4 weeks prior to registration.)
Active infection, ascites, hepatic encephalopathy.
Prior treatment with HAI FUDR.
Patients who have had prior anti EGFR antibody therapy inhibitors and who have not
responded to this treatment will be excluded. However, patients who have responded to
prior anti-EGFR therapy are eligible.)
Female patients who are pregnant or lactating - or planning to become pregnant within
months after the end of the treatment (female patients of child-bearing potential
must have negative pregnancy test ≤ 72 hours before registration).
If a patient has any serious medical problems which may preclude receiving this type
Patients with current evidence of hepatitis A, B, C (ie, active hepatitis)
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.
History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Panitumumab.
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:
Malignancy treated with curative intent and with no known active disease present for ≥
years prior to registration and felt to be at low risk for recurrence by the
Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of
Adequately treated cervical carcinoma in situ without evidence of disease
All locations for NCT01312857
United States (8)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
New York, New York, United States, 10065
Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, United States, 11570
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
View full eligibility
Tris trial is registered with FDA with number: NCT01312857. The sponsor of the trial is Memorial Sloan Kettering Cancer Center and it is looking for 75 volunteers for the current phase.
Official trial title: A Randomized Phase II Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type RAS Who Have Resected Hepatic Metastases From Colorectal Cancer
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