UMIN-CTR Clinical Trial

Public title

Mechanism and prediction of bevacizumab-induced hypertension and proteinuria

Acronym

Study of bevazizumab-induced hypertension and proteinuria

Scientific Title

Mechanism and prediction of bevacizumab-induced hypertension and proteinuria

Scientific Title:Acronym

Study of bevazizumab-induced hypertension and proteinuria

Region

Japan

Condition

Colorectal cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To observe hypertension and proteinuria after bevacizumab administration. And to investigate the serum level of angiogenic factors predict the onset of hypertension and proteinuria.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

To identify whether the biomarkers in blood or urine predict bevacizumab associated hypertension and proteinuria.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Bevacizumab

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed adenocarcinoma of colon or rectum.
2) Unresectable locally advanced or metastatic disease.
3) Age is over 20 years.
4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
5) Patinets with or without measurable or evaluable lesion are eligible.
6) Without history of bevacizumab chemotherapy, without more than 2 chemotherapys, no chemotherapy 4 weeks prior to bevacizumab treatment. History of adjuvant chemotherapy administrated bofore 6 months exclude from prior chemotherapy.
7) Adequate organ function, evidenced by following laboratory results within 14 days prior to randamization.
Leukocyte count<12,000cells/mm3
Absolute neutrophil count<2,000/mm3
Hemoglobin<9.0g/dl
Platelet count<100,000/mm3
Total bilirubin<1.5mg/dl
AST and ALT<2.5 times the upper limit of normal(ULN)
Creatinine<1.5mg/dl
Urine protein/urine creatinine ratio<1.0
8)Signed, written informed concent is obtained.

Key exclusion criteria

1) Current severe infeciton, or suspicious of severe infection with fever greater than 38 degrees centigrade.
2) Sensory neuropathy.
3) Uncontrollable diabetes
4) Uncontrollable hypertension
5) Severe abnormality in electrocardiogram, or cardiovascular disease (e.g., heart failure, angina) with clinical symptom
6) Severe pulmonary disease (e.g., interstitial pneumonia, pulmonary fibrosis, severe pumonary emphysema)
7) Severe systemic disease(e.g., ileus, renal failure, hepatic failure)
8) Clinical or radiographic evidence of brain metastases
9) History of thromboembolism(e.g, myocardial infarction, cerebral infarction, deep venous thromboembolism, pulmonary thrmboembolism)
10) Uncontrollable gastrointestinal ulcer
11) Carcinomatous peritonitis controlled with drainage
12) Any surgery within 4weeks prior to randamization(the exception of implanted port system)
13) Clinical evidence or potential of dysfunction of coagulation
14) Current daily treatment with warfarin
15) Active synchronous cancer
16) Current known infection with HBV or HCV
17) Pregnant or lactating women, or men and women without wanting pregnancy
18) Severe psychiatric disorder
19) Current daily treatment with corticosteroid
20) Severe hypersensitivity to medicine(hypersensitivity to platinum, fluorouracil or 5-HT3 receptor antagonist is ineligible)

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Yasutsuna Sasaki

Organization

Saitama medical university

Division name

Department of medical oncology

Zip code

Address

1397-1 Yamane, Hidaka, Saitama

TEL

Email

Name of contact person

1st name
Middle name
Last name	Toshikado Kaneta

Organization

Saitama medical university

Division name

Department of medical oncology

Zip code

Address

1397-1 Yamane, Hidaka, Saitama

TEL

Homepage URL

Email

Institute

Saitama medical university

Institute

Department

Personal name

Organization

Saitama medical university

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2009

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2009

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2009

Year

10

Month

01

Day

Last follow-up date

2011

Year

12

Month

01

Day

Date of closure to data entry

2018

Year

09

Month

30

Day

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

09

Month

29

Day

Last modified on

2018

Year

10

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002974