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 | Completed Phase 2 Results

• 1 other identifier: 10-137
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Metastatic Colorectal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Participants With Recurrence Free Survival for Colorectal Cancer Participants With Resected Liver Metastases

  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

  15 months

Secondary Outcomes (3)

• Number of Participants Evaluated for Toxicity as Per the NCI Common Toxicity Criteria

  2 years

• Participant Survival

  2 years

• Number of Participants With Tumor Tissue Expression of Predictive Makers

  2 years

Study Arms (2)

Randomization to panitumumab

EXPERIMENTAL

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

Drug: panitumumab

Randomization to No Panitumumab

EXPERIMENTAL

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.

Drug: Randomization to No Panitumumab

Interventions

panitumumab DRUG

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

Randomization to panitumumab

Randomization to No Panitumumab DRUG

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

Randomization to No Panitumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Amgen: collaborator

Study Sites (8)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Rockville Centre

Rockville Centre, New York, 11570, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Publications (1)

• Kemeny NE, Chou JF, Capanu M, Chatila WK, Shi H, Sanchez-Vega F, Kingham TP, Connell LC, Jarnagin WR, D'Angelica MI. A Randomized Phase II Trial of Adjuvant Hepatic Arterial Infusion and Systemic Therapy With or Without Panitumumab After Hepatic Resection of KRAS Wild-type Colorectal Cancer. Ann Surg. 2021 Aug 1;274(2):248-254. doi: 10.1097/SLA.0000000000004923.

  PMID: 33938493 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Nancy Kemeny, MD
• Organization: Memorial Sloan Kettering Cancer Center

kemenyn@MSKCC.ORG

646-888-4180

Study Officials

• Nancy Kemeny, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 11, 2011
• Study Start: March 7, 2011
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: October 9, 2025
• Results First Posted: October 9, 2025

Record last verified: 2024-07

Locations

US (8)