ID

18110

Description

Gemcitabine Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines and/or Taxanes; ODM derived from: https://clinicaltrials.gov/show/NCT00192101

Link

https://clinicaltrials.gov/show/NCT00192101

Keywords

Versions (1)
  1. 10/20/16 10/20/16 -
Uploaded on

October 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00192101

English

Eligibility Metastatic Breast Cancer NCT00192101

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histological or cytological diagnosis of breast carcinoma with evidence of unresectable, locally recurrent, or metastatic disease. lesions should not be amenable to surgery or radiation of curative intent.
Description

Breast Carcinoma unresectable Evidence | Breast cancer recurrent Locally Evidence | Carcinoma breast stage IV Evidence | Lesion Amenable Operative Surgical Procedures | Lesion Amenable Therapeutic radiology procedure Curative intent

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1519810
UMLS CUI [1,3]
C3887511
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C1517927
UMLS CUI [2,3]
C3887511
UMLS CUI [3,1]
C0278488
UMLS CUI [3,2]
C3887511
UMLS CUI [4,1]
C0221198
UMLS CUI [4,2]
C3900053
UMLS CUI [4,3]
C0543467
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C3900053
UMLS CUI [5,3]
C1522449
UMLS CUI [5,4]
C1276305
presence of metastatic or local-regional recurrent disease, according to the american joint committee on cancer
Description

Neoplasm Metastasis | Recurrent disease local regional

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0814836
uni-dimensionally measurable lesions with clearly defined margin that are clearly measurable by following methods according to computerized tomography (ct), chest x-ray or clinical examination, according to recist criteria
Description

Measurable Disease Linear | Lesion Margin Measurable | X-Ray Computed Tomography | Plain chest X-ray | examination; clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C0205132
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0205284
UMLS CUI [2,3]
C1513040
UMLS CUI [3]
C0040405
UMLS CUI [4]
C0039985
UMLS CUI [5]
C1456356
patients with unresectable, locally recurrent or metastatic breast cancer who, were pre-treated with anthracyclines with/without taxanes (paclitaxel, docetaxel)containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study. prior chemotherapy has to be terminated 4 weeks prior. study randomization and disease progression under this therapy has to be documented, also patients must have completely recovered from all acute chemotherapy related toxicities (with exception of alopecia).
Description

Breast Carcinoma unresectable | Breast cancer recurrent Locally | Carcinoma breast stage IV | Anthracycline Antibiotics | Taxanes, antineoplastic | Paclitaxel | docetaxel | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | First line treatment Neoplasm Metastasis | Disease Progression | Chemotherapy Related Toxic effect | Patients Recovered | Alopecia

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C1517927
UMLS CUI [3]
C0278488
UMLS CUI [4]
C0003234
UMLS CUI [5]
C3541958
UMLS CUI [6]
C0144576
UMLS CUI [7]
C0246415
UMLS CUI [8,1]
C0600558
UMLS CUI [8,2]
C3665472
UMLS CUI [9]
C0085533
UMLS CUI [10,1]
C1708063
UMLS CUI [10,2]
C0027627
UMLS CUI [11]
C0242656
UMLS CUI [12,1]
C3665472
UMLS CUI [12,2]
C0439849
UMLS CUI [12,3]
C0600688
UMLS CUI [13,1]
C0030705
UMLS CUI [13,2]
C0521108
UMLS CUI [14]
C0002170
prior radiotherapy must be completed at least 30 days before study entry. patients must have recovered from the acute toxic effects of the treatment prior to study enrollment (except for alopecia). lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
Description

prior radiation therapy Completed | Prior Therapy Related Toxic effect | Patients Recovered | Alopecia | Therapeutic radiology procedure Lesion | Measurable Disease | Tumor Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0205197
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0439849
UMLS CUI [2,3]
C0600688
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C0521108
UMLS CUI [4]
C0002170
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C0221198
UMLS CUI [6]
C1513041
UMLS CUI [7]
C0178874
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have received treatment within the last 30 days with an investigational drug for any indication before study entry.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
concurrent administration of other tumor therapy, including cytotoxic chemotherapy, surgery of cancer, radiotherapy, hormonal therapy and immunotherapy (including herceptin)
Description

cancer treatment | Cytotoxic Chemotherapy | cancer surgery | Therapeutic radiology procedure | Hormone Therapy | Immunotherapy | Herceptin

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0677881
UMLS CUI [3]
C0920424
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0279025
UMLS CUI [6]
C0021083
UMLS CUI [7]
C0338204
active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy, unless adequately treated.
Description

Communicable Disease Affecting Therapeutic procedure | Communicable Disease Treated Adequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205411
serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
Description

Comorbidity Serious Affecting patient safety | Comorbidity Serious Affecting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0392760
UMLS CUI [1,4]
C1113679
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0392760
UMLS CUI [2,4]
C0525058
second primary malignancy that is clinically detectable at the time of consideration for study enrollment(except in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin)
Description

Second Primary Cancers | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated Adequate

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2]
C0851140
UMLS CUI [3,1]
C0007117
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C0205411
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Similar models

Eligibility Metastatic Breast Cancer NCT00192101

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma unresectable Evidence | Breast cancer recurrent Locally Evidence | Carcinoma breast stage IV Evidence | Lesion Amenable Operative Surgical Procedures | Lesion Amenable Therapeutic radiology procedure Curative intent
Item
histological or cytological diagnosis of breast carcinoma with evidence of unresectable, locally recurrent, or metastatic disease. lesions should not be amenable to surgery or radiation of curative intent.
boolean
C0678222 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3887511 (UMLS CUI [1,3])
C0278493 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C3887511 (UMLS CUI [2,3])
C0278488 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0221198 (UMLS CUI [4,1])
C3900053 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
C0221198 (UMLS CUI [5,1])
C3900053 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
C1276305 (UMLS CUI [5,4])
Neoplasm Metastasis | Recurrent disease local regional
Item
presence of metastatic or local-regional recurrent disease, according to the american joint committee on cancer
boolean
C0027627 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0814836 (UMLS CUI [2,2])
Measurable Disease Linear | Lesion Margin Measurable | X-Ray Computed Tomography | Plain chest X-ray | examination; clinical
Item
uni-dimensionally measurable lesions with clearly defined margin that are clearly measurable by following methods according to computerized tomography (ct), chest x-ray or clinical examination, according to recist criteria
boolean
C1513041 (UMLS CUI [1,1])
C0205132 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0205284 (UMLS CUI [2,2])
C1513040 (UMLS CUI [2,3])
C0040405 (UMLS CUI [3])
C0039985 (UMLS CUI [4])
C1456356 (UMLS CUI [5])
Breast Carcinoma unresectable | Breast cancer recurrent Locally | Carcinoma breast stage IV | Anthracycline Antibiotics | Taxanes, antineoplastic | Paclitaxel | docetaxel | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | First line treatment Neoplasm Metastasis | Disease Progression | Chemotherapy Related Toxic effect | Patients Recovered | Alopecia
Item
patients with unresectable, locally recurrent or metastatic breast cancer who, were pre-treated with anthracyclines with/without taxanes (paclitaxel, docetaxel)containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study. prior chemotherapy has to be terminated 4 weeks prior. study randomization and disease progression under this therapy has to be documented, also patients must have completely recovered from all acute chemotherapy related toxicities (with exception of alopecia).
boolean
C0678222 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0278493 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0278488 (UMLS CUI [3])
C0003234 (UMLS CUI [4])
C3541958 (UMLS CUI [5])
C0144576 (UMLS CUI [6])
C0246415 (UMLS CUI [7])
C0600558 (UMLS CUI [8,1])
C3665472 (UMLS CUI [8,2])
C0085533 (UMLS CUI [9])
C1708063 (UMLS CUI [10,1])
C0027627 (UMLS CUI [10,2])
C0242656 (UMLS CUI [11])
C3665472 (UMLS CUI [12,1])
C0439849 (UMLS CUI [12,2])
C0600688 (UMLS CUI [12,3])
C0030705 (UMLS CUI [13,1])
C0521108 (UMLS CUI [13,2])
C0002170 (UMLS CUI [14])
prior radiation therapy Completed | Prior Therapy Related Toxic effect | Patients Recovered | Alopecia | Therapeutic radiology procedure Lesion | Measurable Disease | Tumor Progression
Item
prior radiotherapy must be completed at least 30 days before study entry. patients must have recovered from the acute toxic effects of the treatment prior to study enrollment (except for alopecia). lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
boolean
C0279134 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0600688 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C0521108 (UMLS CUI [3,2])
C0002170 (UMLS CUI [4])
C1522449 (UMLS CUI [5,1])
C0221198 (UMLS CUI [5,2])
C1513041 (UMLS CUI [6])
C0178874 (UMLS CUI [7])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs
Item
have received treatment within the last 30 days with an investigational drug for any indication before study entry.
boolean
C0013230 (UMLS CUI [1])
cancer treatment | Cytotoxic Chemotherapy | cancer surgery | Therapeutic radiology procedure | Hormone Therapy | Immunotherapy | Herceptin
Item
concurrent administration of other tumor therapy, including cytotoxic chemotherapy, surgery of cancer, radiotherapy, hormonal therapy and immunotherapy (including herceptin)
boolean
C0920425 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C0920424 (UMLS CUI [3])
C1522449 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C0021083 (UMLS CUI [6])
C0338204 (UMLS CUI [7])
Communicable Disease Affecting Therapeutic procedure | Communicable Disease Treated Adequate
Item
active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy, unless adequately treated.
boolean
C0009450 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0009450 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
Comorbidity Serious Affecting patient safety | Comorbidity Serious Affecting Protocol Compliance
Item
serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C1113679 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0392760 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
Second Primary Cancers | Carcinoma in situ of uterine cervix | Basal cell carcinoma Treated Adequate
Item
second primary malignancy that is clinically detectable at the time of consideration for study enrollment(except in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin)
boolean
C0751623 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
C0007117 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
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