ID

43940

Description

A Phase I Study of Isolated Hepatic Perfusion With Escalating Dose Melphalan Followed by Postoperative Hepatic Arterial Floxuridine and Leucovorin for Metastatic Unresectable Colorectal Cancers of the Liver; ODM derived from: https://clinicaltrials.gov/show/NCT00001576

Link

https://clinicaltrials.gov/show/NCT00001576

Keywords

Versions (2)
  1. 1/17/16 1/17/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Colorectal Neoplasm NCT00001576

English

Eligibility Colorectal Neoplasm NCT00001576

1 forms  
Criteria
Description

Criteria

patients must not have been previously treated with intrahepatic artery infusional therapy using fudr.
Description

intrahepatic artery infusional therapy using fudr

Data type

boolean

Alias
UMLS CUI [1]
C0016343
patients mush have had no chemotherapy, radiotherapy or biologic therapy for their malignancy in the month prior to the liver perfusion and must have recovered from all side effects.
Description

chemotherapy, radiotherapy or biologic therapy

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0005527
patients must have an ecog performance standard of 0, 1 or 2 on the day prior to treatment.
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
patients must have adequate hepatic function as evidence by bilirubin less than 2.0 and a pt and ptt that are within 1-2 seconds of the upper normal limit.
Description

adequate hepatic function, bilirubin, pt and ptt

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205411
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0033707
UMLS CUI [4]
C0030605
patients must not have biopsy proven cirrhosis or evidence of significant portal hypertension by history, endoscopy, or radiologic studies.
Description

cirrhosis, portal hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0023890
UMLS CUI [2]
C0020541
patients must not have a history of congestive heart failure with an lvef less than 40%.
Description

congestive heart failure, lvef

Data type

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0428772
patients must not have copd or other chronic pulmonary disease with pft's less than 50% predicted for age.
Description

copd, chronic pulmonary disease, pft`s

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0024117
UMLS CUI [3]
C0024119
patients must be 18 years of age or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must have a platelet count greater than 100,000 a hct greater than 27.0, a white blood count greater than 3000/micro liters, and a creatinine less than or equal to 1.5 or a creatinine clearance of greater than 60 ml/min.
Description

platelet count, hct, white blood count, creatinine, creatinine clearance

Data type

boolean

Alias
UMLS CUI [1]
C0005821
UMLS CUI [2]
C0518014
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0201976
UMLS CUI [5]
C0373595
patients must not be pregnant or nursing.
Description

pregnant or nursing.

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients must not be taking immunosuppressive drugs or on chronic anticoagulation.
Description

immunosuppressive drugs, anticoagulation

Data type

boolean

Alias
UMLS CUI [1]
C0021081
UMLS CUI [2]
C0003281
patients must not have an active infection.
Description

active infection

Data type

boolean

Alias
UMLS CUI [1]
C0009488
patients must not have severe allergic reactions to iodine contrast which can not be controlled by premedication with antihistamines and steroids.
Description

iodine contrast agents, premedication with antihistamines and steroids

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0443076
UMLS CUI [2]
C0019590
UMLS CUI [3]
C0038317
patients must not have hiv disease.
Description

hiv

Data type

boolean

Alias
UMLS CUI [1]
C0019682
patients must be aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks. the patient must be willing to sign an informed consent.
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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Similar models

Eligibility Colorectal Neoplasm NCT00001576

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
intrahepatic artery infusional therapy using fudr
Item
patients must not have been previously treated with intrahepatic artery infusional therapy using fudr.
boolean
C0016343 (UMLS CUI [1])
chemotherapy, radiotherapy or biologic therapy
Item
patients mush have had no chemotherapy, radiotherapy or biologic therapy for their malignancy in the month prior to the liver perfusion and must have recovered from all side effects.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0005527 (UMLS CUI [3])
ecog
Item
patients must have an ecog performance standard of 0, 1 or 2 on the day prior to treatment.
boolean
C1520224 (UMLS CUI [1])
adequate hepatic function, bilirubin, pt and ptt
Item
patients must have adequate hepatic function as evidence by bilirubin less than 2.0 and a pt and ptt that are within 1-2 seconds of the upper normal limit.
boolean
C0232741 (UMLS CUI [1,1])
C0205411 (UMLS CUI [1,2])
C1278039 (UMLS CUI [2])
C0033707 (UMLS CUI [3])
C0030605 (UMLS CUI [4])
cirrhosis, portal hypertension
Item
patients must not have biopsy proven cirrhosis or evidence of significant portal hypertension by history, endoscopy, or radiologic studies.
boolean
C0023890 (UMLS CUI [1])
C0020541 (UMLS CUI [2])
congestive heart failure, lvef
Item
patients must not have a history of congestive heart failure with an lvef less than 40%.
boolean
C0018802 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
copd, chronic pulmonary disease, pft`s
Item
patients must not have copd or other chronic pulmonary disease with pft's less than 50% predicted for age.
boolean
C0024115 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0024117 (UMLS CUI [2])
C0024119 (UMLS CUI [3])
Age
Item
patients must be 18 years of age or older.
boolean
C0001779 (UMLS CUI [1])
platelet count, hct, white blood count, creatinine, creatinine clearance
Item
patients must have a platelet count greater than 100,000 a hct greater than 27.0, a white blood count greater than 3000/micro liters, and a creatinine less than or equal to 1.5 or a creatinine clearance of greater than 60 ml/min.
boolean
C0005821 (UMLS CUI [1])
C0518014 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
C0373595 (UMLS CUI [5])
pregnant or nursing.
Item
patients must not be pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
immunosuppressive drugs, anticoagulation
Item
patients must not be taking immunosuppressive drugs or on chronic anticoagulation.
boolean
C0021081 (UMLS CUI [1])
C0003281 (UMLS CUI [2])
active infection
Item
patients must not have an active infection.
boolean
C0009488 (UMLS CUI [1])
iodine contrast agents, premedication with antihistamines and steroids
Item
patients must not have severe allergic reactions to iodine contrast which can not be controlled by premedication with antihistamines and steroids.
boolean
C0020517 (UMLS CUI [1,1])
C0443076 (UMLS CUI [1,2])
C0019590 (UMLS CUI [2])
C0038317 (UMLS CUI [3])
hiv
Item
patients must not have hiv disease.
boolean
C0019682 (UMLS CUI [1])
written informed consent
Item
patients must be aware of the neoplastic nature of his/her illness, the experimental nature of the therapy, alternative treatments, potential benefits, and risks. the patient must be willing to sign an informed consent.
boolean
C0021430 (UMLS CUI [1])
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