ID

37619

Description

Study ID: 104864/612 Clinical Study ID: 104864/612 Study Title: A Prospective, Open Label Phase II Study to Evaluate the Efficacy and Safety of Topotecan (HycamtinTM) in Combination with Carboplatin as First-line Chemotherapy in Patients with Ovarian Cancer Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Topotecan Trade Name: HycamtinTM Study Indication: Ovarian Cancer

Keywords

Versions (1)
  1. 8/11/19 8/11/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

August 11, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Topotecan (HycamtinTM) with Carboplatin as First-Line Chemotherapy in Patients with Ovarian Cancer; 104864/612

English

Eligibility Determination

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Patient Number
Description

Patient number

Data type

integer

Alias
UMLS CUI [1]
C1830427
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Primary diagnosis of histologically-confirmed epithelial carcinoma FIGO stage IC - IV, regardless of measurable or non-measurable disease.
Description

Epithelial Ovarian Cancer, FIGO stage

Data type

boolean

Alias
UMLS CUI [1,1]
C0677886
UMLS CUI [1,2]
C0450454
No prior chemo- or radiotherapy
Description

Prior Chemotherapy; prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C0279134
At least 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Performance status 0-2 (ECOG scale) or >60 (Karnofsky).
Description

ECOG performance status, Karnofsky Performance status

Data type

boolean

Alias
UMLS CUI [1,1]
C1520224
UMLS CUI [1,2]
C0206065
Life expectancy greater than 12 weeks.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Residual tumor < 1.0 cm (optimally debulked).
Description

Residual Tumor

Data type

boolean

Alias
UMLS CUI [1]
C0543478
Adequate hematologic, renal and hepatic function defined as follows: WBC > 3.5 x 10^9/l ANC > 1.5 x 10^9/l Platelet count > 100 x 10^9/l Hemoglobin > 9 g/dl (after transfusion, if needed) Total bilirubin < 1.5 x ULN Alkaline phosphatase < 3 x ULN Estimated GFR > 60 ml/min or Serum creatinine < 150 μmol/l
Description

Hemotologic function; Renal function; Liver function

Data type

boolean

Alias
UMLS CUI [1,1]
C0221130
UMLS CUI [1,2]
C0232804
UMLS CUI [1,3]
C0232741
Patient consent must be obtained according to the local ethics comittee requirements. Patients must be alert and able to give informed consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Non-epithelial tumors or mixed epithelial/non-epithelial tumors or tumors of low malignant potential (borderline tumors).
Description

Epithelioma; Mucinous cystic tumor of borderline malignancy

Data type

boolean

Alias
UMLS CUI [1]
C1368683
UMLS CUI [2]
C0334365
Prior treatment with chemo- or radiotherapy.
Description

Prior Chemotherapy; prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0279134
Residual tumor after surgery > 1 cm.
Description

Residual Tumor

Data type

boolean

Alias
UMLS CUI [1]
C0543478
Active infection or other serious underlying medical condition, which would impair the ability of the patient to be treated according to protocol.
Description

Communicable Disease; Disease

Data type

boolean

Alias
UMLS CUI [1]
C000945
UMLS CUI [2]
C0012634
Dementia or significantly altered mental status that would prohibit understanding and giving informed consent.
Description

Dementia; Abnormal mental state

Data type

boolean

Alias
UMLS CUI [1]
C0497327
UMLS CUI [2]
C0278061
History of allergic reactions to compounds chemically related to carboplatin or topotecan.
Description

Experimental drug, Hypersensitivity

Data type

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0020517
Any other condition or therapy that, in the investigator's opinion, may pose a risk to the patient or interfere with the study objectives?
Description

Other medical condition,at risk; Therapeutic procedure, at risk

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C1444641
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1444641
Past or current history of malignancy other than the entry diagnosis, except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix.
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
Administration of other simultaineous chemotherapeutic drugs or hormonal therapy or simultaneous radiotherapy during the study treatment period or planned whole abdominal radiotherapy.
Description

Chemotherapy, Simultaneous; Hormone therapy, Simultaneous; Therapeutic radiology procedure, Simultaneous

Data type

boolean

Alias
UMLS CUI [1,1]
C3665472
UMLS CUI [1,2]
C0521115
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0521115
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0521115
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Similar models

Eligibility Determination

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Epithelial Ovarian Cancer, FIGO stage
Item
Primary diagnosis of histologically-confirmed epithelial carcinoma FIGO stage IC - IV, regardless of measurable or non-measurable disease.
boolean
C0677886 (UMLS CUI [1,1])
C0450454 (UMLS CUI [1,2])
Prior Chemotherapy; prior radiation therapy
Item
No prior chemo- or radiotherapy
boolean
C1514457 (UMLS CUI [1])
C0279134 (UMLS CUI [2])
Age
Item
At least 18 years of age.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status, Karnofsky Performance status
Item
Performance status 0-2 (ECOG scale) or >60 (Karnofsky).
boolean
C1520224 (UMLS CUI [1,1])
C0206065 (UMLS CUI [1,2])
Life Expectancy
Item
Life expectancy greater than 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Residual Tumor
Item
Residual tumor < 1.0 cm (optimally debulked).
boolean
C0543478 (UMLS CUI [1])
Hemotologic function; Renal function; Liver function
Item
Adequate hematologic, renal and hepatic function defined as follows: WBC > 3.5 x 10^9/l ANC > 1.5 x 10^9/l Platelet count > 100 x 10^9/l Hemoglobin > 9 g/dl (after transfusion, if needed) Total bilirubin < 1.5 x ULN Alkaline phosphatase < 3 x ULN Estimated GFR > 60 ml/min or Serum creatinine < 150 μmol/l
boolean
C0221130 (UMLS CUI [1,1])
C0232804 (UMLS CUI [1,2])
C0232741 (UMLS CUI [1,3])
Informed Consent
Item
Patient consent must be obtained according to the local ethics comittee requirements. Patients must be alert and able to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Epithelioma; Mucinous cystic tumor of borderline malignancy
Item
Non-epithelial tumors or mixed epithelial/non-epithelial tumors or tumors of low malignant potential (borderline tumors).
boolean
C1368683 (UMLS CUI [1])
C0334365 (UMLS CUI [2])
Prior Chemotherapy; prior radiation therapy
Item
Prior treatment with chemo- or radiotherapy.
boolean
C1514457 (UMLS CUI [1,1])
C0279134 (UMLS CUI [1,2])
Residual Tumor
Item
Residual tumor after surgery > 1 cm.
boolean
C0543478 (UMLS CUI [1])
Communicable Disease; Disease
Item
Active infection or other serious underlying medical condition, which would impair the ability of the patient to be treated according to protocol.
boolean
C000945 (UMLS CUI [1])
C0012634 (UMLS CUI [2])
Dementia; Abnormal mental state
Item
Dementia or significantly altered mental status that would prohibit understanding and giving informed consent.
boolean
C0497327 (UMLS CUI [1])
C0278061 (UMLS CUI [2])
Experimental drug, Hypersensitivity
Item
History of allergic reactions to compounds chemically related to carboplatin or topotecan.
boolean
C0304229 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
Other medical condition,at risk; Therapeutic procedure, at risk
Item
Any other condition or therapy that, in the investigator's opinion, may pose a risk to the patient or interfere with the study objectives?
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
Malignant Neoplasms
Item
Past or current history of malignancy other than the entry diagnosis, except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix.
boolean
C0006826 (UMLS CUI [1])
Chemotherapy, Simultaneous; Hormone therapy, Simultaneous; Therapeutic radiology procedure, Simultaneous
Item
Administration of other simultaineous chemotherapeutic drugs or hormonal therapy or simultaneous radiotherapy during the study treatment period or planned whole abdominal radiotherapy.
boolean
C3665472 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0521115 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0521115 (UMLS CUI [3,2])
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