ID

32412

Description

Temsirolimus (Torisel®) and Erlotinib (Tarceva®) in Platinum-Refractory/Ineligible, Advanced, Squamous Cell Carcinoma; ODM derived from: https://clinicaltrials.gov/show/NCT01009203

Link

https://clinicaltrials.gov/show/NCT01009203

Keywords

Versions (1)
  1. 10/31/18 10/31/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 31, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Squamous Cell Carcinoma NCT01009203

English

Eligibility Squamous Cell Carcinoma NCT01009203

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically or cytologically confirmed squamous cell carcinoma of the head and neck, from any primary site. nasopharyngeal carcinoma, who grade i, will be included.
Description

Squamous cell carcinoma of the head and neck | Primary site Any | Nasopharyngeal carcinoma WHO tumor classification

Data type

boolean

Alias
UMLS CUI [1]
C1168401
UMLS CUI [2,1]
C0449695
UMLS CUI [2,2]
C1552551
UMLS CUI [3,1]
C2931822
UMLS CUI [3,2]
C1301142
2. advanced disease, fulfilling one of the criteria defined below:
Description

Advanced disease

Data type

boolean

Alias
UMLS CUI [1]
C0679246
incurable disease as assessed by surgical or radiation oncology
Description

Incurable disease

Data type

boolean

Alias
UMLS CUI [1]
C0175969
metastatic (m1) disease
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
persistent or progressive disease following curative-intent radiation, and not a candidate for surgical salvage due to incurability or morbidity
Description

Persistent Disease | Progressive Disease | Status post Therapeutic radiology procedure Curative intent | Patient Inappropriate Salvage surgery | Etiology Incurable disease | Etiology Morbidity

Data type

boolean

Alias
UMLS CUI [1]
C2983415
UMLS CUI [2]
C1335499
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1522449
UMLS CUI [3,3]
C1276305
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C0442967
UMLS CUI [4,4]
C0543467
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0175969
UMLS CUI [6,1]
C0015127
UMLS CUI [6,2]
C0220880
3. platinum-refractory or platinum-ineligible, fulfilling one of the criteria defined below:
Description

Platinum Refractory | Platinum Ineligible

Data type

boolean

Alias
UMLS CUI [1,1]
C0032207
UMLS CUI [1,2]
C0205269
UMLS CUI [2,1]
C0032207
UMLS CUI [2,2]
C1512714
disease progression during or after 4-6 cycles of platinum-containing therapy in the advanced setting
Description

Disease Progression | Platinum-containing agent Therapy | Course Quantity | Advanced phase

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C2266918
UMLS CUI [2,2]
C0087111
UMLS CUI [3,1]
C0750729
UMLS CUI [3,2]
C1265611
UMLS CUI [4]
C0205179
disease progression within 6 months of curative-intent treatment, which included platinum-based chemotherapy
Description

Disease Progression | Curative treatment | Platinum-based agent Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2]
C1273390
UMLS CUI [3,1]
C2266918
UMLS CUI [3,2]
C0392920
ineligible for platinum-containing therapy, in the opinion of the medical oncologist, due to medical comorbidities or unacceptable risk for toxicity
Description

Ineligibility Platinum-containing agent Therapy | Etiology Comorbidity | Etiology Risk Toxicity

Data type

boolean

Alias
UMLS CUI [1,1]
C1512714
UMLS CUI [1,2]
C2266918
UMLS CUI [1,3]
C0087111
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0009488
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0035647
UMLS CUI [3,3]
C0600688
patient refuses platinum-containing therapy
Description

Platinum-containing agent Therapy Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C2266918
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C1705116
4. measurable disease based on recist
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
disease in previously irradiated sites is considered measurable if there has been unequivocal progression of the lesion after radiotherapy, or the lesion contains residual carcinoma by biopsy more than 6 weeks after completion of radiotherapy
Description

Prior radiation therapy Anatomic Sites | Lesion Progression Post Therapeutic radiology procedure | Measurable Disease | Carcinoma Residual Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C1515974
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0449258
UMLS CUI [2,3]
C0687676
UMLS CUI [2,4]
C1522449
UMLS CUI [3]
C1513041
UMLS CUI [4,1]
C0007097
UMLS CUI [4,2]
C1609982
UMLS CUI [4,3]
C0005558
5. ecog performance status 0-2 at time of informed consent
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. adequate hematologic reserve and organ function
Description

Hematologic function Mass | Organ function

Data type

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C1306372
UMLS CUI [2]
C0678852
absolute neutrophil count > 1200/µl
Description

Absolute neutrophil count

Data type

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 100,000/µl
Description

Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1]
C0032181
renal function: serum creatinine ≤ 1.5x upper limit of normal (uln)
Description

Renal function | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
liver function: total bilirubin ≤ 1.5x uln, ast and alt ≤ 2.5x uln
Description

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
7. able to provide written, voluntary consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
8. patients with reproductive potential must use an effective contraceptive method.
Description

Females & males of reproductive potential Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C4034483
UMLS CUI [1,2]
C0700589
9. male or female, age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
10. life expectancy ≥ 12 weeks
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. nasopharyngeal primary site, if who grade ii or iii
Description

Primary tumor site Nasopharyngeal WHO tumor classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0475447
UMLS CUI [1,2]
C0027442
UMLS CUI [1,3]
C1301142
2. prior treatment blocking the epidermal growth factor receptor (egfr), in the advanced disease setting
Description

Prior Therapy Blocking Epidermal Growth Factor Receptor | Advanced disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332206
UMLS CUI [1,3]
C0034802
UMLS CUI [2]
C0679246
3. prior treatment blocking egfr in the curative-intent setting, if delivered in the previous 6 months
Description

Prior Therapy Blocking Epidermal Growth Factor Receptor | Curative procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0332206
UMLS CUI [1,3]
C0034802
UMLS CUI [2]
C1276305
4. prior treatment with a drug blocking the mammalian target of rapamycin (mtor)
Description

Drug Blocking MTOR

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332206
UMLS CUI [1,3]
C1414805
5. sensitivity to torisel or tarceva
Description

Hypersensitivity Torisel | Hypersensitivity Tarceva

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1951646
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1135136
6. uncontrolled metastatic disease of the central nervous system
Description

CNS metastases Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0205318
7. radiotherapy within the 2 weeks before cycle 1' day 1
Description

Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1522449
8. surgery within the 2 weeks before cycle 1' day 1
Description

Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0543467
9. pregnant or lactating females
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
10. myocardial infarction or ischemia within the 6 months preceding study treatment
Description

Myocardial Infarction | Myocardial Ischemia

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0151744
11. any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
Description

Comorbidity High risk Treatment complications

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0332167
UMLS CUI [1,3]
C0679861
12. no other concurrent, investigational anti-neoplastic agent will be permitted
Description

Antineoplastic Agent Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0003392
UMLS CUI [1,2]
C1517586
13. history of prior malignancy within the prior five years, with the exception of non-melanoma carcinomas of the skin, and carcinoma in situ of the cervix
Description

Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
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Similar models

Eligibility Squamous Cell Carcinoma NCT01009203

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Squamous cell carcinoma of the head and neck | Primary site Any | Nasopharyngeal carcinoma WHO tumor classification
Item
1. histologically or cytologically confirmed squamous cell carcinoma of the head and neck, from any primary site. nasopharyngeal carcinoma, who grade i, will be included.
boolean
C1168401 (UMLS CUI [1])
C0449695 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C2931822 (UMLS CUI [3,1])
C1301142 (UMLS CUI [3,2])
Advanced disease
Item
2. advanced disease, fulfilling one of the criteria defined below:
boolean
C0679246 (UMLS CUI [1])
Incurable disease
Item
incurable disease as assessed by surgical or radiation oncology
boolean
C0175969 (UMLS CUI [1])
Neoplasm Metastasis
Item
metastatic (m1) disease
boolean
C0027627 (UMLS CUI [1])
Persistent Disease | Progressive Disease | Status post Therapeutic radiology procedure Curative intent | Patient Inappropriate Salvage surgery | Etiology Incurable disease | Etiology Morbidity
Item
persistent or progressive disease following curative-intent radiation, and not a candidate for surgical salvage due to incurability or morbidity
boolean
C2983415 (UMLS CUI [1])
C1335499 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
C1276305 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0442967 (UMLS CUI [4,3])
C0543467 (UMLS CUI [4,4])
C0015127 (UMLS CUI [5,1])
C0175969 (UMLS CUI [5,2])
C0015127 (UMLS CUI [6,1])
C0220880 (UMLS CUI [6,2])
Platinum Refractory | Platinum Ineligible
Item
3. platinum-refractory or platinum-ineligible, fulfilling one of the criteria defined below:
boolean
C0032207 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0032207 (UMLS CUI [2,1])
C1512714 (UMLS CUI [2,2])
Disease Progression | Platinum-containing agent Therapy | Course Quantity | Advanced phase
Item
disease progression during or after 4-6 cycles of platinum-containing therapy in the advanced setting
boolean
C0242656 (UMLS CUI [1])
C2266918 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0750729 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0205179 (UMLS CUI [4])
Disease Progression | Curative treatment | Platinum-based agent Chemotherapy
Item
disease progression within 6 months of curative-intent treatment, which included platinum-based chemotherapy
boolean
C0242656 (UMLS CUI [1])
C1273390 (UMLS CUI [2])
C2266918 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
Ineligibility Platinum-containing agent Therapy | Etiology Comorbidity | Etiology Risk Toxicity
Item
ineligible for platinum-containing therapy, in the opinion of the medical oncologist, due to medical comorbidities or unacceptable risk for toxicity
boolean
C1512714 (UMLS CUI [1,1])
C2266918 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0035647 (UMLS CUI [3,2])
C0600688 (UMLS CUI [3,3])
Platinum-containing agent Therapy Refused
Item
patient refuses platinum-containing therapy
boolean
C2266918 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C1705116 (UMLS CUI [1,3])
Measurable Disease
Item
4. measurable disease based on recist
boolean
C1513041 (UMLS CUI [1])
Prior radiation therapy Anatomic Sites | Lesion Progression Post Therapeutic radiology procedure | Measurable Disease | Carcinoma Residual Biopsy
Item
disease in previously irradiated sites is considered measurable if there has been unequivocal progression of the lesion after radiotherapy, or the lesion contains residual carcinoma by biopsy more than 6 weeks after completion of radiotherapy
boolean
C0279134 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0221198 (UMLS CUI [2,1])
C0449258 (UMLS CUI [2,2])
C0687676 (UMLS CUI [2,3])
C1522449 (UMLS CUI [2,4])
C1513041 (UMLS CUI [3])
C0007097 (UMLS CUI [4,1])
C1609982 (UMLS CUI [4,2])
C0005558 (UMLS CUI [4,3])
ECOG performance status
Item
5. ecog performance status 0-2 at time of informed consent
boolean
C1520224 (UMLS CUI [1])
Hematologic function Mass | Organ function
Item
6. adequate hematologic reserve and organ function
boolean
C0221130 (UMLS CUI [1,1])
C1306372 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2])
Absolute neutrophil count
Item
absolute neutrophil count > 1200/µl
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 100,000/µl
boolean
C0032181 (UMLS CUI [1])
Renal function | Creatinine measurement, serum
Item
renal function: serum creatinine ≤ 1.5x upper limit of normal (uln)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
liver function: total bilirubin ≤ 1.5x uln, ast and alt ≤ 2.5x uln
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Informed Consent
Item
7. able to provide written, voluntary consent
boolean
C0021430 (UMLS CUI [1])
Females & males of reproductive potential Contraceptive methods
Item
8. patients with reproductive potential must use an effective contraceptive method.
boolean
C4034483 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Age
Item
9. male or female, age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
10. life expectancy ≥ 12 weeks
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Primary tumor site Nasopharyngeal WHO tumor classification
Item
1. nasopharyngeal primary site, if who grade ii or iii
boolean
C0475447 (UMLS CUI [1,1])
C0027442 (UMLS CUI [1,2])
C1301142 (UMLS CUI [1,3])
Prior Therapy Blocking Epidermal Growth Factor Receptor | Advanced disease
Item
2. prior treatment blocking the epidermal growth factor receptor (egfr), in the advanced disease setting
boolean
C1514463 (UMLS CUI [1,1])
C0332206 (UMLS CUI [1,2])
C0034802 (UMLS CUI [1,3])
C0679246 (UMLS CUI [2])
Prior Therapy Blocking Epidermal Growth Factor Receptor | Curative procedure
Item
3. prior treatment blocking egfr in the curative-intent setting, if delivered in the previous 6 months
boolean
C1514463 (UMLS CUI [1,1])
C0332206 (UMLS CUI [1,2])
C0034802 (UMLS CUI [1,3])
C1276305 (UMLS CUI [2])
Drug Blocking MTOR
Item
4. prior treatment with a drug blocking the mammalian target of rapamycin (mtor)
boolean
C0013227 (UMLS CUI [1,1])
C0332206 (UMLS CUI [1,2])
C1414805 (UMLS CUI [1,3])
Hypersensitivity Torisel | Hypersensitivity Tarceva
Item
5. sensitivity to torisel or tarceva
boolean
C0020517 (UMLS CUI [1,1])
C1951646 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1135136 (UMLS CUI [2,2])
CNS metastases Uncontrolled
Item
6. uncontrolled metastatic disease of the central nervous system
boolean
C0686377 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Therapeutic radiology procedure
Item
7. radiotherapy within the 2 weeks before cycle 1' day 1
boolean
C1522449 (UMLS CUI [1])
Operative Surgical Procedures
Item
8. surgery within the 2 weeks before cycle 1' day 1
boolean
C0543467 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
9. pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Myocardial Infarction | Myocardial Ischemia
Item
10. myocardial infarction or ischemia within the 6 months preceding study treatment
boolean
C0027051 (UMLS CUI [1])
C0151744 (UMLS CUI [2])
Comorbidity High risk Treatment complications
Item
11. any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
boolean
C0009488 (UMLS CUI [1,1])
C0332167 (UMLS CUI [1,2])
C0679861 (UMLS CUI [1,3])
Antineoplastic Agent Investigational
Item
12. no other concurrent, investigational anti-neoplastic agent will be permitted
boolean
C0003392 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
13. history of prior malignancy within the prior five years, with the exception of non-melanoma carcinomas of the skin, and carcinoma in situ of the cervix
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
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