ID

24866

Description

A Phase I Study of Intraperitoneal Hyperthermic Docetaxel; ODM derived from: https://clinicaltrials.gov/show/NCT00474669

Link

https://clinicaltrials.gov/show/NCT00474669

Keywords

Versions (1)
  1. 8/20/17 8/20/17 -
Uploaded on

August 20, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Ovarian Carcinoma NCT00474669

English

Eligibility Ovarian Carcinoma NCT00474669

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have had a complete clinical response (negative clinical examination, ca125 and ct scan of chest, abdomen and pelvis) to front-line therapy for stage ii/iii ovarian, primary peritoneal or fallopian tube carcinoma. this will have included initial surgery followed by combined iv/ip chemotherapy with cisplatin and paclitaxel. patients must have had a minimum of three courses of ip therapy with both paclitaxel and cisplatin
Description

First line treatment Ovarian Carcinoma TNM clinical staging | First line treatment Primary peritoneal carcinoma TNM clinical staging | First line treatment Fallopian Tube Carcinoma TNM clinical staging | Complete remission | Clinical examination Negative | CA-125 Negative Chest | CA-125 Negative Abdomen | CA-125 Negative Pelvis | CT scan Chest Negative | CT scan abdomen Negative | CT scan Pelvis Negative | Operative Surgical Procedure Initial | Combined Modality Therapy | Intravenous chemotherapy | Intraperitoneal chemotherapy Quantity | Cisplatin | Paclitaxel

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0029925
UMLS CUI [1,3]
C3258246
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C1514428
UMLS CUI [2,3]
C3258246
UMLS CUI [3,1]
C1708063
UMLS CUI [3,2]
C0238122
UMLS CUI [3,3]
C3258246
UMLS CUI [4]
C0677874
UMLS CUI [5,1]
C1456356
UMLS CUI [5,2]
C1513916
UMLS CUI [6,1]
C0006610
UMLS CUI [6,2]
C1513916
UMLS CUI [6,3]
C0817096
UMLS CUI [7,1]
C0006610
UMLS CUI [7,2]
C1513916
UMLS CUI [7,3]
C0000726
UMLS CUI [8,1]
C0006610
UMLS CUI [8,2]
C1513916
UMLS CUI [8,3]
C0030797
UMLS CUI [9,1]
C0202823
UMLS CUI [9,2]
C1513916
UMLS CUI [10,1]
C0412620
UMLS CUI [10,2]
C1513916
UMLS CUI [11,1]
C0412628
UMLS CUI [11,2]
C1513916
UMLS CUI [12,1]
C0543467
UMLS CUI [12,2]
C0205265
UMLS CUI [13]
C0009429
UMLS CUI [14]
C0413365
UMLS CUI [15,1]
C0281548
UMLS CUI [15,2]
C1265611
UMLS CUI [16]
C0008838
UMLS CUI [17]
C0144576
second surgery to be performed no more than 3 months from last course of initial chemotherapy
Description

Operative Surgical Procedure second Perform | Chemotherapy Initial

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205436
UMLS CUI [1,3]
C0884358
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0205265
age greater than 18 years and negative pregnancy if has child-bearing potential
Description

Age | Childbearing Potential Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0427780
gog performance status less than 2
Description

GOG performance status

Data type

boolean

Alias
UMLS CUI [1,1]
C1512288
UMLS CUI [1,2]
C1518965
medically fit for surgery
Description

Fit Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C0424576
UMLS CUI [1,2]
C0543467
patients must have normal organ and marrow function as defined in the protocol hepatic function total bilirubin uln ast and alt and alkaline phosphatase must be within the range allowing for eligibility. in determining eligibility the more abnormal of the two values ast or alt) should be used.
Description

Organ function | Bone Marrow function | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0232741
UMLS CUI [4]
C1278039
UMLS CUI [5]
C0201899
UMLS CUI [6]
C0201836
UMLS CUI [7]
C0201850
ability to understand and the willingness to sign a written informed consent document.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
the effects of docetaxel on the developing human fetus are unknown. for this reason and because taxanes are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Description

Docetaxel Fetus drug adverse effect Unknown | Taxanes Teratogenic effect | Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence

Data type

boolean

Alias
UMLS CUI [1,1]
C0246415
UMLS CUI [1,2]
C0920518
UMLS CUI [1,3]
C0439673
UMLS CUI [2,1]
C0796419
UMLS CUI [2,2]
C0232910
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4]
C2985296
UMLS CUI [5]
C0004764
UMLS CUI [6]
C0036899
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have completed front-line therapy for ovarian cancer more than 3 months prior to hipec.
Description

First line treatment Completed Ovarian Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0029925
patients receiving any other investigational agents.
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
patients with stage iv disease including previous parenchymal liver disease, brain metastasis or cytologically-confirmed chest metastasis
Description

Disease TNM clinical staging | Liver disease parenchymal | Metastatic malignant neoplasm to brain | Neoplasm Metastasis Chest

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0745745
UMLS CUI [3]
C0220650
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0817096
patients with a history of severe hypersensitivity reaction to taxotere® or other drugs formulated with polysorbate 80. history of allergic reactions attributed to compounds of similar chemical or biologic composition used in this study in addition to taxotere.
Description

Severe allergy Taxotere | Severe allergy Polysorbate 80 Formulation | Allergic Reaction Compound Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0699967
UMLS CUI [2,1]
C2945656
UMLS CUI [2,2]
C0032601
UMLS CUI [2,3]
C0524527
UMLS CUI [3,1]
C1527304
UMLS CUI [3,2]
C1706082
UMLS CUI [3,3]
C2348205
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.
Description

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

Data type

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]
C0525058
UMLS CUI [6,3]
C0439801
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0525058
UMLS CUI [7,3]
C0439801
more than grade 2 peripheral neuropathy from prior chemotherapy
Description

Peripheral Neuropathy CTCAE Grades | Prior Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
UMLS CUI [2]
C1514457
pregnant, breast-feeding or known to be hiv positive
Description

Pregnancy | Breast Feeding | HIV Seropositivity

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0019699
prior malignancy other than non-melanomatous skin cancer more than 5 years ago
Description

Malignant Neoplasms | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
no prior chemotherapy other than for front-line ovarian cancer or radiation for any reason.
Description

Prior Chemotherapy | Exception First line Chemotherapy Ovarian Carcinoma | Exception Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C0392920
UMLS CUI [2,4]
C0029925
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1522449
stomatitis of any grade
Description

Stomatitis Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0038362
UMLS CUI [1,2]
C0441800
uncontrolled intercurrent illness or other conditions that would limit compliance with study requirements should be excluded.
Description

Comorbidity Uncontrolled Protocol Compliance Limited | Condition Protocol Compliance Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0525058
UMLS CUI [1,4]
C0439801
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0525058
UMLS CUI [2,3]
C0439801
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Similar models

Eligibility Ovarian Carcinoma NCT00474669

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
First line treatment Ovarian Carcinoma TNM clinical staging | First line treatment Primary peritoneal carcinoma TNM clinical staging | First line treatment Fallopian Tube Carcinoma TNM clinical staging | Complete remission | Clinical examination Negative | CA-125 Negative Chest | CA-125 Negative Abdomen | CA-125 Negative Pelvis | CT scan Chest Negative | CT scan abdomen Negative | CT scan Pelvis Negative | Operative Surgical Procedure Initial | Combined Modality Therapy | Intravenous chemotherapy | Intraperitoneal chemotherapy Quantity | Cisplatin | Paclitaxel
Item
patients must have had a complete clinical response (negative clinical examination, ca125 and ct scan of chest, abdomen and pelvis) to front-line therapy for stage ii/iii ovarian, primary peritoneal or fallopian tube carcinoma. this will have included initial surgery followed by combined iv/ip chemotherapy with cisplatin and paclitaxel. patients must have had a minimum of three courses of ip therapy with both paclitaxel and cisplatin
boolean
C1708063 (UMLS CUI [1,1])
C0029925 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1708063 (UMLS CUI [2,1])
C1514428 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
C1708063 (UMLS CUI [3,1])
C0238122 (UMLS CUI [3,2])
C3258246 (UMLS CUI [3,3])
C0677874 (UMLS CUI [4])
C1456356 (UMLS CUI [5,1])
C1513916 (UMLS CUI [5,2])
C0006610 (UMLS CUI [6,1])
C1513916 (UMLS CUI [6,2])
C0817096 (UMLS CUI [6,3])
C0006610 (UMLS CUI [7,1])
C1513916 (UMLS CUI [7,2])
C0000726 (UMLS CUI [7,3])
C0006610 (UMLS CUI [8,1])
C1513916 (UMLS CUI [8,2])
C0030797 (UMLS CUI [8,3])
C0202823 (UMLS CUI [9,1])
C1513916 (UMLS CUI [9,2])
C0412620 (UMLS CUI [10,1])
C1513916 (UMLS CUI [10,2])
C0412628 (UMLS CUI [11,1])
C1513916 (UMLS CUI [11,2])
C0543467 (UMLS CUI [12,1])
C0205265 (UMLS CUI [12,2])
C0009429 (UMLS CUI [13])
C0413365 (UMLS CUI [14])
C0281548 (UMLS CUI [15,1])
C1265611 (UMLS CUI [15,2])
C0008838 (UMLS CUI [16])
C0144576 (UMLS CUI [17])
Operative Surgical Procedure second Perform | Chemotherapy Initial
Item
second surgery to be performed no more than 3 months from last course of initial chemotherapy
boolean
C0543467 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0205265 (UMLS CUI [2,2])
Age | Childbearing Potential Pregnancy test negative
Item
age greater than 18 years and negative pregnancy if has child-bearing potential
boolean
C0001779 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0427780 (UMLS CUI [2,2])
GOG performance status
Item
gog performance status less than 2
boolean
C1512288 (UMLS CUI [1,1])
C1518965 (UMLS CUI [1,2])
Fit Operative Surgical Procedures
Item
medically fit for surgery
boolean
C0424576 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
Organ function | Bone Marrow function | Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
patients must have normal organ and marrow function as defined in the protocol hepatic function total bilirubin uln ast and alt and alkaline phosphatase must be within the range allowing for eligibility. in determining eligibility the more abnormal of the two values ast or alt) should be used.
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0201899 (UMLS CUI [5])
C0201836 (UMLS CUI [6])
C0201850 (UMLS CUI [7])
Informed Consent
Item
ability to understand and the willingness to sign a written informed consent document.
boolean
C0021430 (UMLS CUI [1])
Docetaxel Fetus drug adverse effect Unknown | Taxanes Teratogenic effect | Childbearing Potential Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
the effects of docetaxel on the developing human fetus are unknown. for this reason and because taxanes are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C0246415 (UMLS CUI [1,1])
C0920518 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,3])
C0796419 (UMLS CUI [2,1])
C0232910 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C2985296 (UMLS CUI [4])
C0004764 (UMLS CUI [5])
C0036899 (UMLS CUI [6])
Item Group
C0680251 (UMLS CUI)
First line treatment Completed Ovarian Carcinoma
Item
patients who have completed front-line therapy for ovarian cancer more than 3 months prior to hipec.
boolean
C1708063 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0029925 (UMLS CUI [1,3])
Investigational New Drugs
Item
patients receiving any other investigational agents.
boolean
C0013230 (UMLS CUI [1])
Disease TNM clinical staging | Liver disease parenchymal | Metastatic malignant neoplasm to brain | Neoplasm Metastasis Chest
Item
patients with stage iv disease including previous parenchymal liver disease, brain metastasis or cytologically-confirmed chest metastasis
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0745745 (UMLS CUI [2])
C0220650 (UMLS CUI [3])
C0027627 (UMLS CUI [4,1])
C0817096 (UMLS CUI [4,2])
Severe allergy Taxotere | Severe allergy Polysorbate 80 Formulation | Allergic Reaction Compound Similar
Item
patients with a history of severe hypersensitivity reaction to taxotere® or other drugs formulated with polysorbate 80. history of allergic reactions attributed to compounds of similar chemical or biologic composition used in this study in addition to taxotere.
boolean
C2945656 (UMLS CUI [1,1])
C0699967 (UMLS CUI [1,2])
C2945656 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
C0524527 (UMLS CUI [2,3])
C1527304 (UMLS CUI [3,1])
C1706082 (UMLS CUI [3,2])
C2348205 (UMLS CUI [3,3])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Protocol Compliance Limited | Social situation Protocol Compliance Limited
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])
C0525058 (UMLS CUI [6,2])
C0439801 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0525058 (UMLS CUI [7,2])
C0439801 (UMLS CUI [7,3])
Peripheral Neuropathy CTCAE Grades | Prior Chemotherapy
Item
more than grade 2 peripheral neuropathy from prior chemotherapy
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2])
Pregnancy | Breast Feeding | HIV Seropositivity
Item
pregnant, breast-feeding or known to be hiv positive
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0019699 (UMLS CUI [3])
Malignant Neoplasms | Exception Skin carcinoma
Item
prior malignancy other than non-melanomatous skin cancer more than 5 years ago
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Prior Chemotherapy | Exception First line Chemotherapy Ovarian Carcinoma | Exception Therapeutic radiology procedure
Item
no prior chemotherapy other than for front-line ovarian cancer or radiation for any reason.
boolean
C1514457 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])
C0029925 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C1522449 (UMLS CUI [3,2])
Stomatitis Grade
Item
stomatitis of any grade
boolean
C0038362 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Comorbidity Uncontrolled Protocol Compliance Limited | Condition Protocol Compliance Limited
Item
uncontrolled intercurrent illness or other conditions that would limit compliance with study requirements should be excluded.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
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