ID

15391

Beschrijving

Phase I and Pharmacology Study of Camptothecin-20-O-Propionate Hydrate (CZ48) in Patients With Solid Tumors or Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00947739

Link

https://clinicaltrials.gov/show/NCT00947739

Trefwoorden

  1. 29-05-16 29-05-16 -
Geüploaded op

29 mei 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Advanced Solid Tumors NCT00947739

Eligibility Advanced Solid Tumors NCT00947739

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
all patients, 18 years of age or older, with incurable advanced solid tumors or lymphomas are eligible.
Beschrijving

solid tumors or lymphomas

Datatype

boolean

Alias
UMLS CUI [1]
C0280100
UMLS CUI [2]
C0024299
patients must have a zubrod performance status of 0-1.
Beschrijving

zubrod performance

Datatype

boolean

Alias
UMLS CUI [1]
C3714786
patients must sign an informed consent document.
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 -along with an absence of a red blood cell transfusion in the two weeks prior to their participation in the trial.
Beschrijving

bone marrow function

Datatype

boolean

Alias
UMLS CUI [1]
C0412480
patients should have adequate hepatic function with a total bilirubin within normal range and sgot or sgpt < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine within the upper limit of normal.
Beschrijving

hepatic function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
patients may receive no other concurrent anticancer treatments such as chemotherapy, hormonotherapy (except for prostate cancer patients on lhrh agonists), immunotherapy, biological agents, investigational agents, or radiation therapy during this trial, and should be off these treatments for at least 2 weeks, or until they have completely recovered from the side effects of these treatments, whichever is longest, except for persistent grade 1 neuropathy in patients who received prior platinum or taxanes.
Beschrijving

concurrent anticancer treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0920425
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with symptomatic brain metastases are excluded from this study.
Beschrijving

brain metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
pregnant women or nursing mothers are not eligible for this trial. patients of child bearing potential must use adequate contraception (contraceptive pill, or iud, or two mechanical barriers).
Beschrijving

contraception

Datatype

boolean

Alias
UMLS CUI [1]
C0420837
UMLS CUI [2]
C0549206
patients with severe uncontrolled medical problems are not eligible for this trial.
Beschrijving

uncontrolled medical problems

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0009488
patients who have too much esterase activity in the blood, with a conversion rate yielding concentration of cpt > 20 ng/ml in vitro. please see section 6.5 for sample collection, preparation and shipping. a validated analysis will be performed according to sponsor sop sfcr.ph.r.01.
Beschrijving

esterase activity

Datatype

boolean

Alias
UMLS CUI [1]
C1149811

Similar models

Eligibility Advanced Solid Tumors NCT00947739

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
solid tumors or lymphomas
Item
all patients, 18 years of age or older, with incurable advanced solid tumors or lymphomas are eligible.
boolean
C0280100 (UMLS CUI [1])
C0024299 (UMLS CUI [2])
zubrod performance
Item
patients must have a zubrod performance status of 0-1.
boolean
C3714786 (UMLS CUI [1])
informed consent
Item
patients must sign an informed consent document.
boolean
C0021430 (UMLS CUI [1])
bone marrow function
Item
patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of > 1,500 or cells/mm3 and platelet count >100,000/mm3 -along with an absence of a red blood cell transfusion in the two weeks prior to their participation in the trial.
boolean
C0412480 (UMLS CUI [1])
hepatic function
Item
patients should have adequate hepatic function with a total bilirubin within normal range and sgot or sgpt < two times the upper limit of normal, and adequate renal function as defined by a serum creatinine within the upper limit of normal.
boolean
C0232741 (UMLS CUI [1])
concurrent anticancer treatment
Item
patients may receive no other concurrent anticancer treatments such as chemotherapy, hormonotherapy (except for prostate cancer patients on lhrh agonists), immunotherapy, biological agents, investigational agents, or radiation therapy during this trial, and should be off these treatments for at least 2 weeks, or until they have completely recovered from the side effects of these treatments, whichever is longest, except for persistent grade 1 neuropathy in patients who received prior platinum or taxanes.
boolean
C0920425 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
brain metastases
Item
patients with symptomatic brain metastases are excluded from this study.
boolean
C0220650 (UMLS CUI [1])
contraception
Item
pregnant women or nursing mothers are not eligible for this trial. patients of child bearing potential must use adequate contraception (contraceptive pill, or iud, or two mechanical barriers).
boolean
C0420837 (UMLS CUI [1])
C0549206 (UMLS CUI [2])
uncontrolled medical problems
Item
patients with severe uncontrolled medical problems are not eligible for this trial.
boolean
C0525058 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
esterase activity
Item
patients who have too much esterase activity in the blood, with a conversion rate yielding concentration of cpt > 20 ng/ml in vitro. please see section 6.5 for sample collection, preparation and shipping. a validated analysis will be performed according to sponsor sop sfcr.ph.r.01.
boolean
C1149811 (UMLS CUI [1])

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