ID

31802

Description

A Phase II Trial of Perifosine Following Tyrosine Kinase Inhibitor (TKI) - Failure in Patients With Renal Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00448721

Link

https://clinicaltrials.gov/show/NCT00448721

Keywords

Versions (1)
  1. 9/28/18 9/28/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 28, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Renal Cell Carcinoma NCT00448721

English

Eligibility Renal Cell Carcinoma NCT00448721

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients will be required to have clear cell renal cell carcinoma with less than 50% of any other histology (papillary or chromophobe or oncocytic). there must be histologic confirmation by the treating center of either the primary or a metastatic lesion
Description

Clear cell renal cell carcinoma | Papillary Renal Cell Carcinoma Percentage | Chromophobe Renal Cell Carcinoma Percentage | Renal Cell Carcinoma Oncocytic Percentage | Primary Lesion | Metastatic Lesion

Data type

boolean

Alias
UMLS CUI [1]
C0279702
UMLS CUI [2,1]
C1306837
UMLS CUI [2,2]
C0439165
UMLS CUI [3,1]
C1266042
UMLS CUI [3,2]
C0439165
UMLS CUI [4,1]
C0007134
UMLS CUI [4,2]
C1378050
UMLS CUI [4,3]
C0439165
UMLS CUI [5]
C1402294
UMLS CUI [6]
C1513183
patients must have experienced disease progression by recist criteria while on sorafenib or sunitinib
Description

Disease Progression | sorafenib | sunitinib

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C1516119
UMLS CUI [3]
C1176020
patients must be off of sorafenib or sunitinib for >= 2 weeks prior to initiation of perifosine and <= 3 months prior to enrollment
Description

Sorafenib Discontinued | Sunitinib Discontinued | perifosine

Data type

boolean

Alias
UMLS CUI [1,1]
C1516119
UMLS CUI [1,2]
C1444662
UMLS CUI [2,1]
C1176020
UMLS CUI [2,2]
C1444662
UMLS CUI [3]
C0754570
patients may have had sorafenib or sunitinib in the adjuvant setting as long as they have experienced disease recurrence while on therapy
Description

Sorafenib Adjuvant therapy | Sunitinib Adjuvant therapy | Disease recurrence

Data type

boolean

Alias
UMLS CUI [1,1]
C1516119
UMLS CUI [1,2]
C0677850
UMLS CUI [2,1]
C1176020
UMLS CUI [2,2]
C0677850
UMLS CUI [3]
C0679254
patients must have measurable disease that is not curable by standard radiation therapy or surgery
Description

Measurable Disease | Therapeutic radiology procedure Unsuccessful | Operative Surgical Procedures Unsuccessful

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C1272705
UMLS CUI [3,1]
C0543467
UMLS CUI [3,2]
C1272705
age >= 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
ecog performance status 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
- patients must have the ability to understand and willingness to sign a written informed consent document
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history or clinical evidence of cns disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastasis, or history of stroke
Description

CNS disorder | Brain Tumor, Primary | Seizures Uncontrolled | Metastatic malignant neoplasm to brain | Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0750974
UMLS CUI [3,1]
C0036572
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0220650
UMLS CUI [5]
C0038454
other than sorafenib or sunitinib, patients may have only had prior immunotherapy for stage iv disease
Description

Prior Immunotherapy Disease TNM clinical staging allowed | Exception Sorafenib | Exception Sunitinib

Data type

boolean

Alias
UMLS CUI [1,1]
C1514461
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C3258246
UMLS CUI [1,4]
C0683607
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1516119
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1176020
patients may have had prior sorafenib or sunitinib and cannot have been treated with both tkis
Description

Sorafenib Previous allowed | Sunitinib Previous allowed | Tyrosine kinase inhibitor Both

Data type

boolean

Alias
UMLS CUI [1,1]
C1516119
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0683607
UMLS CUI [2,1]
C1176020
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0683607
UMLS CUI [3,1]
C1268567
UMLS CUI [3,2]
C1706086
patients who have stopped sorafenib or sunitinib due to toxicity but have only progressed off therapy will not be allowed
Description

Sorafenib Discontinued Due to Toxicity | Sunitinib Discontinued Due to Toxicity | Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C1516119
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0600688
UMLS CUI [2,1]
C1176020
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0678226
UMLS CUI [2,4]
C0600688
UMLS CUI [3]
C0242656
patients may have had prior anti-angiogenic such as bevacizumab only if given in combination with either sorafenib or sunitinib
Description

Angiogenesis Inhibitors allowed | Bevacizumab allowed | Relationship Combination Sorafenib | Relationship Combination Sunitinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0596087
UMLS CUI [1,2]
C0683607
UMLS CUI [2,1]
C0796392
UMLS CUI [2,2]
C0683607
UMLS CUI [3,1]
C0439849
UMLS CUI [3,2]
C0205195
UMLS CUI [3,3]
C1516119
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0205195
UMLS CUI [4,3]
C1176020
prior thalidomide or ifnα are allowed for adjuvant therapy or stage iv disease
Description

Thalidomide allowed Adjuvant therapy | Interferon-alpha allowed Adjuvant therapy | Thalidomide allowed Disease TNM clinical staging | Interferon-alpha allowed Disease TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0039736
UMLS CUI [1,2]
C0683607
UMLS CUI [1,3]
C0677850
UMLS CUI [2,1]
C0002199
UMLS CUI [2,2]
C0683607
UMLS CUI [2,3]
C0677850
UMLS CUI [3,1]
C0039736
UMLS CUI [3,2]
C0683607
UMLS CUI [3,3]
C0012634
UMLS CUI [3,4]
C3258246
UMLS CUI [4,1]
C0002199
UMLS CUI [4,2]
C0683607
UMLS CUI [4,3]
C0012634
UMLS CUI [4,4]
C3258246
patients may not have had prior mtor inhibitors (cci-779, rad001)
Description

mTOR Inhibitors | CCI 779 | RAD 001

Data type

boolean

Alias
UMLS CUI [1]
C1515672
UMLS CUI [2]
C0796512
UMLS CUI [3]
C0962969
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Similar models

Eligibility Renal Cell Carcinoma NCT00448721

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Clear cell renal cell carcinoma | Papillary Renal Cell Carcinoma Percentage | Chromophobe Renal Cell Carcinoma Percentage | Renal Cell Carcinoma Oncocytic Percentage | Primary Lesion | Metastatic Lesion
Item
patients will be required to have clear cell renal cell carcinoma with less than 50% of any other histology (papillary or chromophobe or oncocytic). there must be histologic confirmation by the treating center of either the primary or a metastatic lesion
boolean
C0279702 (UMLS CUI [1])
C1306837 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C1266042 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C0007134 (UMLS CUI [4,1])
C1378050 (UMLS CUI [4,2])
C0439165 (UMLS CUI [4,3])
C1402294 (UMLS CUI [5])
C1513183 (UMLS CUI [6])
Disease Progression | sorafenib | sunitinib
Item
patients must have experienced disease progression by recist criteria while on sorafenib or sunitinib
boolean
C0242656 (UMLS CUI [1])
C1516119 (UMLS CUI [2])
C1176020 (UMLS CUI [3])
Sorafenib Discontinued | Sunitinib Discontinued | perifosine
Item
patients must be off of sorafenib or sunitinib for >= 2 weeks prior to initiation of perifosine and <= 3 months prior to enrollment
boolean
C1516119 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1176020 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0754570 (UMLS CUI [3])
Sorafenib Adjuvant therapy | Sunitinib Adjuvant therapy | Disease recurrence
Item
patients may have had sorafenib or sunitinib in the adjuvant setting as long as they have experienced disease recurrence while on therapy
boolean
C1516119 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C1176020 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0679254 (UMLS CUI [3])
Measurable Disease | Therapeutic radiology procedure Unsuccessful | Operative Surgical Procedures Unsuccessful
Item
patients must have measurable disease that is not curable by standard radiation therapy or surgery
boolean
C1513041 (UMLS CUI [1])
C1522449 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
C0543467 (UMLS CUI [3,1])
C1272705 (UMLS CUI [3,2])
Age
Item
age >= 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
- patients must have the ability to understand and willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS disorder | Brain Tumor, Primary | Seizures Uncontrolled | Metastatic malignant neoplasm to brain | Cerebrovascular accident
Item
history or clinical evidence of cns disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastasis, or history of stroke
boolean
C0007682 (UMLS CUI [1])
C0750974 (UMLS CUI [2])
C0036572 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0220650 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
Prior Immunotherapy Disease TNM clinical staging allowed | Exception Sorafenib | Exception Sunitinib
Item
other than sorafenib or sunitinib, patients may have only had prior immunotherapy for stage iv disease
boolean
C1514461 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0683607 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C1516119 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1176020 (UMLS CUI [3,2])
Sorafenib Previous allowed | Sunitinib Previous allowed | Tyrosine kinase inhibitor Both
Item
patients may have had prior sorafenib or sunitinib and cannot have been treated with both tkis
boolean
C1516119 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C1176020 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0683607 (UMLS CUI [2,3])
C1268567 (UMLS CUI [3,1])
C1706086 (UMLS CUI [3,2])
Sorafenib Discontinued Due to Toxicity | Sunitinib Discontinued Due to Toxicity | Disease Progression
Item
patients who have stopped sorafenib or sunitinib due to toxicity but have only progressed off therapy will not be allowed
boolean
C1516119 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0600688 (UMLS CUI [1,4])
C1176020 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0678226 (UMLS CUI [2,3])
C0600688 (UMLS CUI [2,4])
C0242656 (UMLS CUI [3])
Angiogenesis Inhibitors allowed | Bevacizumab allowed | Relationship Combination Sorafenib | Relationship Combination Sunitinib
Item
patients may have had prior anti-angiogenic such as bevacizumab only if given in combination with either sorafenib or sunitinib
boolean
C0596087 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0796392 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0439849 (UMLS CUI [3,1])
C0205195 (UMLS CUI [3,2])
C1516119 (UMLS CUI [3,3])
C0439849 (UMLS CUI [4,1])
C0205195 (UMLS CUI [4,2])
C1176020 (UMLS CUI [4,3])
Thalidomide allowed Adjuvant therapy | Interferon-alpha allowed Adjuvant therapy | Thalidomide allowed Disease TNM clinical staging | Interferon-alpha allowed Disease TNM clinical staging
Item
prior thalidomide or ifnα are allowed for adjuvant therapy or stage iv disease
boolean
C0039736 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
C0677850 (UMLS CUI [1,3])
C0002199 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0677850 (UMLS CUI [2,3])
C0039736 (UMLS CUI [3,1])
C0683607 (UMLS CUI [3,2])
C0012634 (UMLS CUI [3,3])
C3258246 (UMLS CUI [3,4])
C0002199 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
C0012634 (UMLS CUI [4,3])
C3258246 (UMLS CUI [4,4])
mTOR Inhibitors | CCI 779 | RAD 001
Item
patients may not have had prior mtor inhibitors (cci-779, rad001)
boolean
C1515672 (UMLS CUI [1])
C0796512 (UMLS CUI [2])
C0962969 (UMLS CUI [3])
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