Clinical Trials /

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

NCT01312857

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: 10-137
  • NCT ID: NCT01312857

Conditions

  • Metastatic Colorectal Cancer

Interventions

DrugSynonymsArms
panitumumabRandomization to panitumumab
Randomization to No PanitumumabRandomization to No Panitumumab

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Randomization to panitumumabExperimentalPatients whose liver metastases have been completely resected will be randomized Arm A will receive Panitumumab in addition to HAI FUDR/Dexamethasone plus systemic CPT-11/5FU/LV
  • panitumumab
Randomization to No PanitumumabExperimentalPatients whose liver metastases have been completely resected will be randomized and patients randomized to Arm B will receive HAI FUDR/Dex plus systemic CPT-11/5FU/LV alone.
  • Randomization to No Panitumumab

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:to determine if panitumumab with Hepatic Arterial Infusion (HAI) in combination with systemic chemotherapy can increase the recurrence free survival (RFS) for colorectal cancer patients with resected liver metastases
Time Frame:2 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:to assess toxicity as per the NCI Common Toxicity Criteria
Time Frame:Day 1 of each cycle
Safety Issue:
Description:Toxicities will be recorded as adverse events on the Adverse Event case report form and must be graded using The National Cancer Institute's Common Toxicity Criteria (CTC)version 4.0 with the exception of skin- or nail-related toxicities, which must be graded using CTC version 3.0 with modifications
Measure:to determine survival
Time Frame:2 years
Safety Issue:
Description:
Measure:to analyze tumor tissue for predictive biomarkers
Time Frame:2 years
Safety Issue:
Description:(such as NRAS, BRAF, PIK3CA, AKT1 and MEK1), and correlate with patient progression and survival following therapy.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • colon
  • rectal
  • liver
  • AMG 954 (Panitumumab)
  • DEXAMETHASONE
  • FLOXURIDINE
  • FLUOROURACIL
  • IRINOTECAN (CPT-11) CAMPTOSAR
  • LEUCOVORIN
  • 10-137

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