New combo aims to extend cancer remission after liver surgery
NCT ID NCT01312857
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding the targeted drug panitumumab to standard chemotherapy (given through the liver artery and a vein) could help keep colorectal cancer from returning after liver metastases were surgically removed. It involved 75 adults with a specific gene type (wild-type RAS) and no cancer outside the liver. The goal was to see if the combination could lengthen the time patients stayed cancer-free.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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75 people
The number who actually took part.
- Started
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Mar 2011
- Finished
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Jul 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 at MSKCC. * Completely resected hepatic metastases without current evidence of other metastatic disease. * 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 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: (≤ 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 Karnofsky) * Histologically confirmed all RAS wild type. * Paraffin-embedded tumor tissue obtained from the primary tumor or metastasis (Prior to Exclusion Criteria: * 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 6 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 of treatment. * 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 ≥ 3 years prior to registration and felt to be at low risk for recurrence by the treating physician * Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease * Adequately treated cervical carcinoma in situ without evidence of disease
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering Rockville Centre
Rockville Centre, New York, 11570, United States
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Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
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Other studies related to the condition(s) this trial covers.
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