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.
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
Drug | Synonyms | Arms |
---|
panitumumab | | Randomization to panitumumab |
Randomization to No Panitumumab | | Randomization 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
Name | Type | Description | Interventions |
---|
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 | |
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. | - 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: | Active, not 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
Last Updated
April 2, 2021