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A Randomized Phase II Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type KRAS Who Have Resected Hepatic Metastases From Colorectal Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colorectal Cancer

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Trial Information

A Randomized Phase II Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type KRAS Who Have Resected Hepatic Metastases From Colorectal Cancer


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 within 14 days prior to registration:

- WBC > or = to 3.0 K/uL

- ANC > 1.5 K/uL

- Platelets > or = to 100,000/uL

- Creatinine <1.5 mg/dL

- HGB > or = to 9 gm/dL 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:

- 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)

- 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 enrollment/ randomization.)

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

- 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
enrollment/randomization

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

- Histologically confirmed KRAS wild type(G12 mutations are not eligible. All other
mutations are eligible).

- Paraffin-embedded tumor tissue obtained from the primary tumor or metastasis

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 enrollment).

- 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 randomization 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Nancy Kemeny, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

10-137

NCT ID:

NCT01312857

Start Date:

March 2011

Completion Date:

March 2014

Related Keywords:

  • Metastatic Colorectal Cancer
  • colon
  • rectal
  • liver
  • AMG 954 (Panitumumab)
  • DEXAMETHASONE
  • FLOXURIDINE
  • FLUOROURACIL
  • IRINOTECAN (CPT-11) CAMPTOSAR
  • LEUCOVORIN
  • 10-137
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Memorial Sloan-Kettering Cancer Center at Basking RidgeBasking Ridge, New Jersey  07920
Memorial Sloan-Kettering Cancer Center at Mercy Medical CenterRockville Centre, New York  11570
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital CenterSleepy Hollow, New York  10591
Memorial Sloan-Kettering Cancer Center @ SuffolkCommack, New York  11725