Study of Hepatic Arterial Infusion With Intravenous Irino... | NCT01312857

NCT01312857

Status Module

Sponsor/Collaborators Module

Name	Class
Amgen	INDUSTRY

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of Participants Evaluated for Toxicity as Per the NCI Common Toxicity Criteria	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	2 years

Eligibility Module

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

Contacts/Locations Module

Name	Affiliation	Role
Nancy Kemeny, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Basking Ridge		Basking Ridge	New Jersey	07920	United States
Memorial Sloan Kettering Monmouth

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33938493	Derived	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.

Label	URL
Memorial Sloan Kettering Cancer Center	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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 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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Apr 15, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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 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
BG001	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. 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
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00037 BG00138 BG00275

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Title	Measurements
	BG00052(27 to 75) BG00153(33 to 75) BG00253(27 to 75)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00012 BG00117 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0003 BG0014 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00037 BG00138 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

Posted

Number

95% Confidence Interval

percentage of participants

15 months

ID	Title	Description
OG000	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 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
OG001	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. 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

Units	Counts
Participants	OG00037 OG00138

Title

Denominators

Categories

Title	Measurements
	OG00069(53 to 82) OG00147(32 to 63)

Secondary

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

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

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	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 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
OG001	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. 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

Secondary

Participant Survival

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	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 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
OG001	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. 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

Secondary

Number of Participants With Tumor Tissue Expression of Predictive Makers

(such as NRAS, BRAF, PIK3CA, AKT1 and MEK1), and correlate with patient progression and survival following therapy.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	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 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
OG001	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. 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

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 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	15	37	14	37	27	37
EG001	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. 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	27	38	6	38	26	38

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0006 affected37 at risk EG0012 affected38 at risk
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Anorexia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected37 at risk EG0011 affected38 at risk
Hyperbilirubinemia	Investigations	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Chills	General disorders	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Colonic obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0002 affected37 at risk EG0011 affected38 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Enteritis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Fatigue	General disorders	Systematic Assessment	EG0001 affected37 at risk EG0011 affected38 at risk
Fever	General disorders	Systematic Assessment	EG0003 affected37 at risk EG0011 affected38 at risk
Fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Leukocytes	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0002 affected37 at risk EG0011 affected38 at risk
Pain - Other	General disorders	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Presyncope	Nervous system disorders	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Rectal anastomotic leak	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Renal and urinary disorders - Other	Renal and urinary disorders	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Surgical and medical procedures - Other	Surgical and medical procedures	Systematic Assessment	EG0001 affected37 at risk EG0013 affected38 at risk
Thromboembolic event	Vascular disorders	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0003 affected37 at risk EG0011 affected38 at risk
Weight loss	Investigations	Systematic Assessment	EG0000 affected37 at risk EG0011 affected38 at risk
Wound infection	Infections and infestations	Systematic Assessment	EG0002 affected37 at risk EG0010 affected38 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG00012 affected37 at risk EG00111 affected38 at risk
Alkaline phosphatase increased	Investigations	Systematic Assessment	EG0004 affected37 at risk EG0013 affected38 at risk
Blood bilirubin increased	Investigations	Systematic Assessment	EG0001 affected37 at risk EG0011 affected38 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG0008 affected37 at risk EG0014 affected38 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0009 affected37 at risk EG0010 affected38 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected37 at risk EG0012 affected38 at risk
Neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 affected37 at risk EG0013 affected38 at risk
Lymphopenia	Investigations	Systematic Assessment	EG0004 affected37 at risk EG0012 affected38 at risk
Hypophosphatemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected37 at risk EG0010 affected38 at risk
Paronychia	Infections and infestations	Systematic Assessment	EG0001 affected37 at risk EG0010 affected38 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0004 affected37 at risk EG0010 affected38 at risk

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D000077544	Panitumumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

Units	Counts
Participants	OG00037 OG00138