ID

14314

Description

Oxaliplatin in Cancer Patients With Impaired Kidney Function; ODM derived from: https://clinicaltrials.gov/show/NCT00001835

Link

https://clinicaltrials.gov/show/NCT00001835

Keywords

Versions (1)
  1. 4/10/16 4/10/16 -
Uploaded on

April 10, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Kidney Disease NCT00001835

English

Eligibility Kidney Disease NCT00001835

1 forms  
Criteria
Description

Criteria

patients with prior chemotherapy, radiation therapy, hormonal therapy and immunotherapy are allowed with the exception that patients cannot have had prior treatment with oxaliplatin.
Description

Prior treatment

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0021083
UMLS CUI [5,1]
C0332300
UMLS CUI [5,2]
C0069717
patients greater than or equal to 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients must have an ecog performance status less than or equal to 2 (karnofsky greater than or equal to 60 percent) and a life expectancy of at least 3 months.
Description

Performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
UMLS CUI [3]
C0023671
patients must have adequate organ and marrow function which includes:
Description

Organ and marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0542341
leukocytes must be greater than or equal to 3,000/microliter.
Description

Leukocytes count

Data type

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count must be greater than or equal to 1,500/microliter.
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count must be greater than or equal to 100,000/microliter.
Description

Platelet count

Data type

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin within normal institutional limits.
Description

Total bilirubin

Data type

boolean

Alias
UMLS CUI [1]
C0201913
ast (sgot)/alt(sgpt) less than or equal to 1.5 times the upper limit of normal.
Description

Ast (sgot)/alt(sgpt)

Data type

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
patients with no evidence of clinically significant neuropathy.
Description

Neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0442874
women of child-bearing potential and men must agree to use adequate contraception.
Description

Contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
patients must have the ability to understand and the willingness to sign a written informed consent document.
Description

Written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study, or within 6 weeks of prior platinum therapy will be excluded.
Description

Prior treatment

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C2266918
UMLS CUI [4]
C2348558
patients undergoing therapy with other investigational agents will be excluded.
Description

Investigational agents

Data type

boolean

Alias
UMLS CUI [1]
C1875319
patients with known brain metastases will be excluded.
Description

Brain metastases

Data type

boolean

Alias
UMLS CUI [1]
C0220650
patients with a history of an allergy to platinum compounds will be excluded.
Description

Allergy to platinum compounds

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2266854
patients with uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia will be excluded.
Description

Comorbidity

Data type

boolean

Alias
UMLS CUI [1]
C0009488
women must not be pregnant or nursing.
Description

Gynaecological status

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients must not be hiv-positive or receiving anti-retroviral therapy (haart).
Description

HIV and anti-retroviral therapy

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0887947
patients actively receiving renal dialysis treatments while on the study will be excluded.
Description

Renal dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0011946
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Similar models

Eligibility Kidney Disease NCT00001835

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Prior treatment
Item
patients with prior chemotherapy, radiation therapy, hormonal therapy and immunotherapy are allowed with the exception that patients cannot have had prior treatment with oxaliplatin.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0332300 (UMLS CUI [5,1])
C0069717 (UMLS CUI [5,2])
Age
Item
patients greater than or equal to 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Performance status
Item
patients must have an ecog performance status less than or equal to 2 (karnofsky greater than or equal to 60 percent) and a life expectancy of at least 3 months.
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
C0023671 (UMLS CUI [3])
Organ and marrow function
Item
patients must have adequate organ and marrow function which includes:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0542341 (UMLS CUI [2,2])
Leukocytes count
Item
leukocytes must be greater than or equal to 3,000/microliter.
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count must be greater than or equal to 1,500/microliter.
boolean
C0948762 (UMLS CUI [1])
Platelet count
Item
platelet count must be greater than or equal to 100,000/microliter.
boolean
C0032181 (UMLS CUI [1])
Total bilirubin
Item
total bilirubin within normal institutional limits.
boolean
C0201913 (UMLS CUI [1])
Ast (sgot)/alt(sgpt)
Item
ast (sgot)/alt(sgpt) less than or equal to 1.5 times the upper limit of normal.
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Neuropathy
Item
patients with no evidence of clinically significant neuropathy.
boolean
C0442874 (UMLS CUI [1])
Contraception
Item
women of child-bearing potential and men must agree to use adequate contraception.
boolean
C0700589 (UMLS CUI [1])
Written informed consent
Item
patients must have the ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Prior treatment
Item
patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study, or within 6 weeks of prior platinum therapy will be excluded.
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C2266918 (UMLS CUI [3])
C2348558 (UMLS CUI [4])
Investigational agents
Item
patients undergoing therapy with other investigational agents will be excluded.
boolean
C1875319 (UMLS CUI [1])
Brain metastases
Item
patients with known brain metastases will be excluded.
boolean
C0220650 (UMLS CUI [1])
Allergy to platinum compounds
Item
patients with a history of an allergy to platinum compounds will be excluded.
boolean
C0020517 (UMLS CUI [1,1])
C2266854 (UMLS CUI [1,2])
Comorbidity
Item
patients with uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, or unstable angina pectoris, or cardiac arrhythmia will be excluded.
boolean
C0009488 (UMLS CUI [1])
Gynaecological status
Item
women must not be pregnant or nursing.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV and anti-retroviral therapy
Item
patients must not be hiv-positive or receiving anti-retroviral therapy (haart).
boolean
C0019699 (UMLS CUI [1])
C0887947 (UMLS CUI [2])
Renal dialysis
Item
patients actively receiving renal dialysis treatments while on the study will be excluded.
boolean
C0011946 (UMLS CUI [1])
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