ID

32410

Beskrivning

Azacitidine and Cisplatin for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck; ODM derived from: https://clinicaltrials.gov/show/NCT00443261

Länk

https://clinicaltrials.gov/show/NCT00443261

Nyckelord

Versioner (1)
  1. 2018-10-31 2018-10-31 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

31 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma NCT00443261

Engelsk

Eligibility Squamous Cell Carcinoma NCT00443261

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histologically proven scchn that is either metastatic or has persisted or recurred following definitive surgery and/or radiation therapy, and is not amenable to salvage surgical resection.
Beskrivning

SCCHN metastatic | SCCHN Persistent | SCCHN Recurrent | Status post Operative Surgical Procedures | Status post Therapeutic radiology procedure | SCCHN Inappropriate Salvage Excision

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1168401
UMLS CUI [1,2]
C1522484
UMLS CUI [2,1]
C1168401
UMLS CUI [2,2]
C0205322
UMLS CUI [3,1]
C1168401
UMLS CUI [3,2]
C2945760
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0543467
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C1522449
UMLS CUI [6,1]
C1168401
UMLS CUI [6,2]
C1548788
UMLS CUI [6,3]
C0442967
UMLS CUI [6,4]
C0728940
patients may have received previous chemotherapy and/or biological treatment (such as cetuximab) 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.
Beskrivning

Prior Chemotherapy Recurrent disease | Biological treatment Recurrent disease | cetuximab | Prior Chemotherapy Neoplasm Metastasis | Biological treatment Neoplasm Metastasis | Prior therapy Completed | Nitrosoureas | Mitomycin | Toxicity resolved

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0277556
UMLS CUI [2,1]
C1531518
UMLS CUI [2,2]
C0277556
UMLS CUI [3]
C0995188
UMLS CUI [4,1]
C1514457
UMLS CUI [4,2]
C0027627
UMLS CUI [5,1]
C1531518
UMLS CUI [5,2]
C0027627
UMLS CUI [6,1]
C1514463
UMLS CUI [6,2]
C0205197
UMLS CUI [7]
C0028210
UMLS CUI [8]
C0002475
UMLS CUI [9,1]
C0600688
UMLS CUI [9,2]
C1514893
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).
Beskrivning

Prior radiation therapy Completed | Toxicity resolved

Datatyp

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 before entry into the study and all complications/adverse events must have been resolved.
Beskrivning

Operative Surgical Procedures Completed | Complications resolved | Adverse events resolved

Datatyp

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
patients must have at least one lesion amenable to serial biopsy.
Beskrivning

Lesion Quantity Amenable Biopsy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3900053
UMLS CUI [1,4]
C0005558
age greater than 18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status less than 2 (karnofsky greater than 60%).
Beskrivning

ECOG performance status | Karnofsky Performance Status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0206065
life expectancy of greater than 3 months.
Beskrivning

Life Expectancy

Datatyp

boolean

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

Organ function | Bone Marrow function

Datatyp

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 (ie, radiation, chemotherapy, immunotherapy, biological therapy or gene therapy) for scchn while they are on this study.
Beskrivning

Therapeutic radiology procedure Absent SCCHN | Chemotherapy Absent SCCHN | Immunotherapy Absent SCCHN | Biological treatment Absent SCCHN | Gene therapy Absent SCCHN

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C1168401
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C1168401
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C1168401
UMLS CUI [4,1]
C1531518
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C1168401
UMLS CUI [5,1]
C0017296
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C1168401
women of childbearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
Beskrivning

Childbearing Potential Serum pregnancy test negative | Azacitidine

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must not be planning to receive any other concurrent therapy (ie, radiation, chemotherapy, immunotherapy, biological therapy, investigational agents or gene therapy) for scchn while they are on this study.
Beskrivning

Therapeutic radiology procedure SCCHN | Chemotherapy SCCHN | Immunotherapy SCCHN | Biological treatment SCCHN | Investigational New Drugs | Gene therapy SCCHN

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1168401
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1168401
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C1168401
UMLS CUI [4,1]
C1531518
UMLS CUI [4,2]
C1168401
UMLS CUI [5]
C0013230
UMLS CUI [6,1]
C0017296
UMLS CUI [6,2]
C1168401
patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
Beskrivning

Metastatic malignant neoplasm to brain | Poor prognosis Expected | Progressive neurologic dysfunction Interferes with Evaluation Neurological event | Progressive neurologic dysfunction Interferes with Evaluation Adverse events

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2,1]
C0278252
UMLS CUI [2,2]
C1517001
UMLS CUI [3,1]
C4013375
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1261322
UMLS CUI [3,4]
C1320718
UMLS CUI [4,1]
C4013375
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1261322
UMLS CUI [4,4]
C0877248
history of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, cisplatin and mannitol or other agents used in study.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C2348205
UMLS CUI [1,4]
C0004475
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1706082
UMLS CUI [2,3]
C2348205
UMLS CUI [2,4]
C0008838
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C1706082
UMLS CUI [3,3]
C2348205
UMLS CUI [3,4]
C0024730
UMLS CUI [4,1]
C1527304
UMLS CUI [4,2]
C1706082
UMLS CUI [4,3]
C2348205
UMLS CUI [4,4]
C0013230
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.
Beskrivning

Pregnancy | Breast Feeding | Chemotherapeutic agents At risk Fetal | Chemotherapeutic agents At risk Fetal Death | Females & males of reproductive potential Contraceptive methods Required

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0003392
UMLS CUI [3,2]
C1444641
UMLS CUI [3,3]
C0521457
UMLS CUI [4,1]
C0003392
UMLS CUI [4,2]
C1444641
UMLS CUI [4,3]
C0015927
UMLS CUI [5,1]
C4034483
UMLS CUI [5,2]
C0700589
UMLS CUI [5,3]
C1514873
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.
Beskrivning

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

Datatyp

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.
Beskrivning

HIV Seropositivity | Potential Interference Endpoints

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C3245505
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
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.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
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 [5,1]
C1705847
UMLS CUI [5,2]
C1707251
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
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Similar models

Eligibility Squamous Cell Carcinoma NCT00443261

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
SCCHN metastatic | SCCHN Persistent | SCCHN Recurrent | Status post Operative Surgical Procedures | Status post Therapeutic radiology procedure | SCCHN Inappropriate Salvage Excision
Item
patients must have histologically proven scchn 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 [1,1])
C1522484 (UMLS CUI [1,2])
C1168401 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
C1168401 (UMLS CUI [3,1])
C2945760 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
C0231290 (UMLS CUI [5,1])
C1522449 (UMLS CUI [5,2])
C1168401 (UMLS CUI [6,1])
C1548788 (UMLS CUI [6,2])
C0442967 (UMLS CUI [6,3])
C0728940 (UMLS CUI [6,4])
Prior Chemotherapy Recurrent disease | Biological treatment Recurrent disease | cetuximab | Prior Chemotherapy Neoplasm Metastasis | Biological treatment Neoplasm Metastasis | Prior therapy Completed | Nitrosoureas | Mitomycin | Toxicity resolved
Item
patients may have received previous chemotherapy and/or biological treatment (such as cetuximab) 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.
boolean
C1514457 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C1531518 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
C0995188 (UMLS CUI [3])
C1514457 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C1531518 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
C1514463 (UMLS CUI [6,1])
C0205197 (UMLS CUI [6,2])
C0028210 (UMLS CUI [7])
C0002475 (UMLS CUI [8])
C0600688 (UMLS CUI [9,1])
C1514893 (UMLS CUI [9,2])
Prior radiation therapy Completed | Toxicity 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 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])
Lesion Quantity Amenable Biopsy
Item
patients must have at least one lesion amenable to serial biopsy.
boolean
C0221198 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3900053 (UMLS CUI [1,3])
C0005558 (UMLS CUI [1,4])
Age
Item
age greater than 18 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
ecog performance status less than 2 (karnofsky greater than 60%).
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
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])
Therapeutic radiology procedure Absent SCCHN | Chemotherapy Absent SCCHN | Immunotherapy Absent SCCHN | Biological treatment Absent SCCHN | Gene therapy Absent SCCHN
Item
patients must not be planning to receive any other concurrent therapy (ie, radiation, chemotherapy, immunotherapy, biological therapy or gene therapy) for scchn while they are on this study.
boolean
C1522449 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1168401 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1168401 (UMLS CUI [2,3])
C0021083 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1168401 (UMLS CUI [3,3])
C1531518 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1168401 (UMLS CUI [4,3])
C0017296 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C1168401 (UMLS CUI [5,3])
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)
Therapeutic radiology procedure SCCHN | Chemotherapy SCCHN | Immunotherapy SCCHN | Biological treatment SCCHN | Investigational New Drugs | Gene therapy SCCHN
Item
patients must not be planning to receive any other concurrent therapy (ie, radiation, chemotherapy, immunotherapy, biological therapy, investigational agents or gene therapy) for scchn while they are on this study.
boolean
C1522449 (UMLS CUI [1,1])
C1168401 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C1168401 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C1168401 (UMLS CUI [3,2])
C1531518 (UMLS CUI [4,1])
C1168401 (UMLS CUI [4,2])
C0013230 (UMLS CUI [5])
C0017296 (UMLS CUI [6,1])
C1168401 (UMLS CUI [6,2])
Metastatic malignant neoplasm to brain | Poor prognosis Expected | Progressive neurologic dysfunction Interferes with Evaluation Neurological event | Progressive neurologic dysfunction Interferes with Evaluation Adverse events
Item
patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
boolean
C0220650 (UMLS CUI [1])
C0278252 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
C4013375 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C1320718 (UMLS CUI [3,4])
C4013375 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
C0877248 (UMLS CUI [4,4])
Allergic Reaction Compound Similar Azacitidine | Allergic Reaction Compound Similar Cisplatin | Allergic Reaction Compound Similar Mannitol | Allergic Reaction Compound Similar Investigational New Drugs
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])
C2348205 (UMLS CUI [1,3])
C0004475 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C1706082 (UMLS CUI [2,2])
C2348205 (UMLS CUI [2,3])
C0008838 (UMLS CUI [2,4])
C1527304 (UMLS CUI [3,1])
C1706082 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
C0024730 (UMLS CUI [3,4])
C1527304 (UMLS CUI [4,1])
C1706082 (UMLS CUI [4,2])
C2348205 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])
Pregnancy | Breast Feeding | Chemotherapeutic agents At risk Fetal | Chemotherapeutic agents At risk Fetal Death | Females & males of reproductive potential Contraceptive methods Required
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])
C0003392 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C0521457 (UMLS CUI [3,3])
C0003392 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0015927 (UMLS CUI [4,3])
C4034483 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
C1514873 (UMLS CUI [5,3])
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 | Potential Interference 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])
C3245505 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2349179 (UMLS CUI [2,3])
Malignant Neoplasms | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix | Exception Cancer Other Free of Duration
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])
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])
C1705847 (UMLS CUI [5,1])
C1707251 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
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