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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01312857
First received: March 8, 2011
Last updated: April 24, 2014
Last verified: April 2014

March 8, 2011
April 24, 2014
March 2011
March 2015   (final data collection date for primary 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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01312857 on ClinicalTrials.gov Archive Site
  • to assess toxicity as per the NCI Common Toxicity Criteria [ Time Frame: Day 1 of each cycle ] [ Designated as safety issue: Yes ]
    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
  • to determine survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • to analyze tumor tissue for predictive biomarkers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    (such as NRAS, BRAF, PIK3CA, AKT1 and MEK1), and correlate with patient progression and survival following therapy.
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Colorectal Cancer
  • Drug: panitumumab

    All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.

    All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization to panitumumab 6 mg/kg day 15 and 29 Each cycle repeats every 36 days for a total of 6 cycles

  • Drug: Randomization to No Panitumumab

    All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.

    All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization (to no panitumumab) Each cycle repeats every 36 days for a total of 6 cycles

  • Experimental: Randomization to panitumumab
    Patients 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
    Intervention: Drug: panitumumab
  • Experimental: Randomization to No Panitumumab
    Patients 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.
    Intervention: Drug: Randomization to No Panitumumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
78
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Nancy Kemeny, MD 646-888-4180
Contact: Michael D'Angelica, MD 212-639-3226
United States
 
NCT01312857
10-137
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Amgen
Principal Investigator: Nancy Kemeny, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP