ID

31187

Beschreibung

Azacitidine and Cisplatin in Patients With Advanced Lung or Head and Neck Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00901537

Link

https://clinicaltrials.gov/show/NCT00901537

Stichworte

Versionen (1)
  1. 25.07.18 25.07.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. Juli 2018

DOI

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Lizenz

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Eligibility Non-small Cell Lung Cancer NCT00901537

Englisch

Eligibility Non-small Cell Lung Cancer NCT00901537

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histologically proven squamous cell carcinoma of head and neck or non-small cell lung cancer that is either metastatic or has persisted or recurred following definitive surgery and/or radiation therapy, and is not amenable to salvage surgical resection.
Beschreibung

Squamous cell carcinoma of the head and neck | Non-small cell lung cancer metastatic | Non-Small Cell Lung Carcinoma Persistent | Non-small cell lung cancer recurrent | Status post Operative Surgical Procedures | Status post Therapeutic radiology procedure | Non-Small Cell Lung Carcinoma Inappropriate Salvage Excision

Datentyp

boolean

Alias
UMLS CUI [1]
C1168401
UMLS CUI [2]
C0278987
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C0205322
UMLS CUI [4]
C0278517
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0543467
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C1522449
UMLS CUI [7,1]
C0007131
UMLS CUI [7,2]
C1548788
UMLS CUI [7,3]
C0442967
UMLS CUI [7,4]
C0728940
patients may have received previous chemotherapy and/or biological treatment such as cetuximab, bevacizumab or erlotinib) for the recurrent or metastatic disease. prior treatment must have been completed at least 28 days (42 days for nitrosoureas or mitomycin c) prior to entering the study and all toxicities must have been resolved. patients who have received prior treatment with egfr inhibitor alone such as cetuximab or erlotinib are allowed to enter the study at least 14 days after receiving the last dose of the prior treatment.
Beschreibung

Prior Chemotherapy Recurrent disease | Biological treatment Previous Recurrent disease | Prior Chemotherapy Neoplasm Metastasis | Biological treatment Previous Neoplasm Metastasis | cetuximab | bevacizumab | erlotinib | Prior Therapy Completed | Nitrosoureas | Mitomycin | Toxicities resolved | EGFR inhibitor Alone allowed

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0277556
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0277556
UMLS CUI [3,1]
C1514457
UMLS CUI [3,2]
C0027627
UMLS CUI [4,1]
C1531518
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C0027627
UMLS CUI [5]
C0995188
UMLS CUI [6]
C0796392
UMLS CUI [7]
C1135135
UMLS CUI [8,1]
C1514463
UMLS CUI [8,2]
C0205197
UMLS CUI [9]
C0028210
UMLS CUI [10]
C0002475
UMLS CUI [11,1]
C0600688
UMLS CUI [11,2]
C1514893
UMLS CUI [12,1]
C1443775
UMLS CUI [12,2]
C0205171
UMLS CUI [12,3]
C0683607
prior radiation must have been completed at least 28 days before entry into the study and all toxicities must have been resolved (no more than 3000 cgy to fields including substantial marrow).
Beschreibung

Prior radiation therapy Completed | Toxicities resolved

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C1514893
surgery must have been completed at least 28 days 28 days before entry into the study and all complications/adverse events must have been resolved.
Beschreibung

Operative Surgical Procedures Completed | Complications resolved | Adverse events resolved

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C0009566
UMLS CUI [2,2]
C1514893
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C1514893
age >18 years.
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status <2 (karnofsky >60%).
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of greater than 3 months.
Beschreibung

Life Expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
patients must have normal organ and marrow function
Beschreibung

Organ function | Bone Marrow function

Datentyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
patients must not be planning to receive any other concurrent therapy (i.e. radiation, chemotherapy, immunotherapy, biological therapy or gene therapy) while they are on this study.
Beschreibung

Absence Therapeutic procedure Planned | Therapeutic radiology procedure Absent | Chemotherapy Absent | Immunotherapy Absent | Biological treatment Absent | Gene therapy Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0021083
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1531518
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0017296
UMLS CUI [6,2]
C0332197
patients must be able to understand and sign a written informed consent document approved for this trial.
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
Beschreibung

Childbearing Potential Serum pregnancy test negative | Azacitidine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430061
UMLS CUI [2]
C0004475
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with symptomatic brain metastases are excluded from this clinical trial. patients with asymptomatic brain metastases are allowed. the patient must be stable for 2 weeks after radiotherapy; if the patient is on corticosteroids, the dose of cortico steroids must have been stable for 2 weeks prior to first dose of study treatment, or be in the process of being tapered.
Beschreibung

Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Asymptomatic allowed | Patients Stable status Post Therapeutic radiology procedure | Adrenal Cortex Hormones Dose Stable | Adrenal Cortex Hormones Dosage tapering

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231221
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0205360
UMLS CUI [3,3]
C0687676
UMLS CUI [3,4]
C1522449
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205360
UMLS CUI [5,1]
C0001617
UMLS CUI [5,2]
C1827449
history of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, cisplatin and mannitol or other agents used in study.
Beschreibung

Allergic Reaction Compound Azacitidine Similar | Allergic Reaction Compound Cisplatin Similar | Allergic Reaction Compound Mannitol Similar | Allergic Reaction Compound Investigational New Drugs Similar

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C0004475
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C0008838
UMLS CUI [2,4]
C2348205
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C1706082
UMLS CUI [3,3]
C0024730
UMLS CUI [3,4]
C2348205
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C1706082
UMLS CUI [4,3]
C0013230
UMLS CUI [4,4]
C2348205
pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents. women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Beschreibung

Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C4034483
UMLS CUI [3,2]
C0700589
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Beschreibung

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
patients known to be hiv-positive are not eligible because of the potential to confound this study's endpoints.
Beschreibung

HIV Seropositivity Interferes with Endpoints

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019699
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2349179
no prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.
Beschreibung

Malignant Neoplasms Previous | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Cancer Other Disease Free of

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1707251
UMLS CUI [5,3]
C0012634
UMLS CUI [5,4]
C0332296
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Ähnliche Modelle

Eligibility Non-small Cell Lung Cancer NCT00901537

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of the head and neck | Non-small cell lung cancer metastatic | Non-Small Cell Lung Carcinoma Persistent | Non-small cell lung cancer recurrent | Status post Operative Surgical Procedures | Status post Therapeutic radiology procedure | Non-Small Cell Lung Carcinoma Inappropriate Salvage Excision
Item
patients must have histologically proven squamous cell carcinoma of head and neck or non-small cell lung cancer that is either metastatic or has persisted or recurred following definitive surgery and/or radiation therapy, and is not amenable to salvage surgical resection.
boolean
C1168401 (UMLS CUI [1])
C0278987 (UMLS CUI [2])
C0007131 (UMLS CUI [3,1])
C0205322 (UMLS CUI [3,2])
C0278517 (UMLS CUI [4])
C0231290 (UMLS CUI [5,1])
C0543467 (UMLS CUI [5,2])
C0231290 (UMLS CUI [6,1])
C1522449 (UMLS CUI [6,2])
C0007131 (UMLS CUI [7,1])
C1548788 (UMLS CUI [7,2])
C0442967 (UMLS CUI [7,3])
C0728940 (UMLS CUI [7,4])
Prior Chemotherapy Recurrent disease | Biological treatment Previous Recurrent disease | Prior Chemotherapy Neoplasm Metastasis | Biological treatment Previous Neoplasm Metastasis | cetuximab | bevacizumab | erlotinib | Prior Therapy Completed | Nitrosoureas | Mitomycin | Toxicities resolved | EGFR inhibitor Alone allowed
Item
patients may have received previous chemotherapy and/or biological treatment such as cetuximab, bevacizumab or erlotinib) for the recurrent or metastatic disease. prior treatment must have been completed at least 28 days (42 days for nitrosoureas or mitomycin c) prior to entering the study and all toxicities must have been resolved. patients who have received prior treatment with egfr inhibitor alone such as cetuximab or erlotinib are allowed to enter the study at least 14 days after receiving the last dose of the prior treatment.
boolean
C1514457 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0277556 (UMLS CUI [2,3])
C1514457 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C1531518 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C0027627 (UMLS CUI [4,3])
C0995188 (UMLS CUI [5])
C0796392 (UMLS CUI [6])
C1135135 (UMLS CUI [7])
C1514463 (UMLS CUI [8,1])
C0205197 (UMLS CUI [8,2])
C0028210 (UMLS CUI [9])
C0002475 (UMLS CUI [10])
C0600688 (UMLS CUI [11,1])
C1514893 (UMLS CUI [11,2])
C1443775 (UMLS CUI [12,1])
C0205171 (UMLS CUI [12,2])
C0683607 (UMLS CUI [12,3])
Prior radiation therapy Completed | Toxicities resolved
Item
prior radiation must have been completed at least 28 days before entry into the study and all toxicities must have been resolved (no more than 3000 cgy to fields including substantial marrow).
boolean
C0279134 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
Operative Surgical Procedures Completed | Complications resolved | Adverse events resolved
Item
surgery must have been completed at least 28 days 28 days before entry into the study and all complications/adverse events must have been resolved.
boolean
C0543467 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0009566 (UMLS CUI [2,1])
C1514893 (UMLS CUI [2,2])
C0877248 (UMLS CUI [3,1])
C1514893 (UMLS CUI [3,2])
Age
Item
age >18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status <2 (karnofsky >60%).
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 3 months.
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
patients must have normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Absence Therapeutic procedure Planned | Therapeutic radiology procedure Absent | Chemotherapy Absent | Immunotherapy Absent | Biological treatment Absent | Gene therapy Absent
Item
patients must not be planning to receive any other concurrent therapy (i.e. radiation, chemotherapy, immunotherapy, biological therapy or gene therapy) while they are on this study.
boolean
C0332197 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0021083 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1531518 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0017296 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Informed Consent
Item
patients must be able to understand and sign a written informed consent document approved for this trial.
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Serum pregnancy test negative | Azacitidine
Item
women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0004475 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Asymptomatic allowed | Patients Stable status Post Therapeutic radiology procedure | Adrenal Cortex Hormones Dose Stable | Adrenal Cortex Hormones Dosage tapering
Item
patients with symptomatic brain metastases are excluded from this clinical trial. patients with asymptomatic brain metastases are allowed. the patient must be stable for 2 weeks after radiotherapy; if the patient is on corticosteroids, the dose of cortico steroids must have been stable for 2 weeks prior to first dose of study treatment, or be in the process of being tapered.
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0687676 (UMLS CUI [3,3])
C1522449 (UMLS CUI [3,4])
C0001617 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205360 (UMLS CUI [4,3])
C0001617 (UMLS CUI [5,1])
C1827449 (UMLS CUI [5,2])
Allergic Reaction Compound Azacitidine Similar | Allergic Reaction Compound Cisplatin Similar | Allergic Reaction Compound Mannitol Similar | Allergic Reaction Compound Investigational New Drugs Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, cisplatin and mannitol or other agents used in study.
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0004475 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C0008838 (UMLS CUI [2,3])
C2348205 (UMLS CUI [2,4])
C1527304 (UMLS CUI [3,1])
C1706082 (UMLS CUI [3,2])
C0024730 (UMLS CUI [3,3])
C2348205 (UMLS CUI [3,4])
C1527304 (UMLS CUI [4,1])
C1706082 (UMLS CUI [4,2])
C0013230 (UMLS CUI [4,3])
C2348205 (UMLS CUI [4,4])
Pregnancy | Breast Feeding | Females & males of reproductive potential Contraceptive methods
Item
pregnant or nursing women may not participate in this trial because of the increased risk of fetal harm including fetal death from the chemotherapeutic agents. women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C4034483 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
HIV Seropositivity Interferes with Endpoints
Item
patients known to be hiv-positive are not eligible because of the potential to confound this study's endpoints.
boolean
C0019699 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2349179 (UMLS CUI [1,3])
Malignant Neoplasms Previous | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated | Exception Cancer Other Disease Free of
Item
no prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1707251 (UMLS CUI [5,2])
C0012634 (UMLS CUI [5,3])
C0332296 (UMLS CUI [5,4])
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