UMIN-CTR Clinical Trial

Public title

A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)

Acronym

A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)

Scientific Title

A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)

Scientific Title:Acronym

A phase II study to evaluate the effectiveness of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer who cannot undergo common protocol (OGSG 0802)

Region

Japan

Condition

patients with advanced/recurrent colon cancer who cannot undergo common protocol

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

A response and adverse events of l-LV/5-FU (mRPMI regimen) + Bevacizumab for patients with advanced/recurrent colon cancer are evaluated on patients with some disorder who cannot be registered to common protocol.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Overall Response Rate (ORR)

Key secondary outcomes

Incidence of Adverse Events, and their grades
Progression-Free Survival (PFS)
Overall Survival (OS)
Incidence of Completion of the regimen

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

l-LV 250 mg/m2 IV over 2 hours, followed by a slow IV dose of 5-FU 600 mg/m2 during the first hour. This is repeated three times each week and the drug is withdrawn for one week. Dosing will be repeated for one course of 4 weeks until one of the criteria for discontinuation of study treatment is met.
Bevacizumab is injected intravenously at a dose of 5 mg/kg (body weight) every 2 weeks. Dosing is repeated until one of the criteria for discontinuation of study treatment is met.

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) colon cancer diagnosed pathologically
2) primary advanced colon cancer and/or metastatic colon cancer
3) with measurable lesion
4) without any prior chemotherapy or with 180 days period after
postoperative chemotherapy
5) expected more than 3 months of survival
6) patients without any severe disorder in bone marrow, lung, liver, or
kidney and satisfies the body conditions
1. Hb >= 9.0g/dL
2. WBC 4,000-12,000/mm3
3. Neutrocyte >= 1,500mm3
4. platelet >= 100,000/mm3
5. Total-bilirubin <= 1.5 mg/dL
6. AST, ALT >= 100U/L or 200U/L for patients with liver metastasis
7. sCr <= 1.2mg/dL
8. CCR >= 50mL/min
[Cockcroft-Gault]expected=[(140 - age)x body weight]/[72 x sCr]
7) with normal ECG within 28 days
8) IC form written by patient
9) patients who have at least one of these functions
1. Patients cannot be registered for l-OHP/CPT-11 therapy by a doctor
2. ECOG PS 1-2
3. age >= 65 years old
4. sAlb < 3.5 g/dl
5. prior radiation therapy for pelvic/abdominal lesions

Key exclusion criteria

1) ECOG PS 3-4
2) with a brain tumor or brain metastasis
3) with double cancer diagnosed within 5 years except for basal cell
Carcinoma, CIS of portion, and/or CIS of digestive tract treated
curatively
4) with a symptom of neuro-vascular disorder on the brain
5) without surgical treatment, open biopsy, and/or suturing of injury
6) with plans of surgical operation during this regimen
7) with easy bleeding and/or coagulation disorder
8) with a history of thrombosis
9) with an ulcer on the digestive tracts which is uncontrollable
10) with inflammation of abdominal organs
11) with a disorder of the kidney which needs some therapies
12) with an uncontrolled hypertension
13) with a severe allergy to fluorouracil. Levohorinate calcium
14)patients with a lack of enzyme; DPD (dihydropyridine dehydrogenase) or with adverse events due to fluoropyrimidine
15) with an uncontrollable diarrhea
16) with interstitial pneumonia or pulmonary fibrosis
17) patients who need immuno-suppressive medicines after an organ transplantation
18) with an uncontrollable infection
19) pregnant females, nursing mothers, or pregnancy test-positive females
20) males who do not protect against pregnancy
21) patients whose doctor cannot register for this study

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Takeshi Kato

Organization

Mino City Hospital

Division name

Dpt.Surgery

Zip code

Address

5-7-1 kasano, Minou City, Osaka 562-8562

TEL

072-728-2001

Email

Name of contact person

1st name
Middle name
Last name	Takeshi Kato

Organization

Mino City Hospital

Division name

Dpt.Surgery

Zip code

Address

5-7-1 kasano, Minou City, Osaka 562-8562

TEL

072-728-2001

Homepage URL

Email

Institute

Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)

Institute

Department

Personal name

Organization

Osaka Clinical Study Supporting Organization

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

07

Month

10

Day

URL releasing protocol

https://link.springer.com/article/10.1007%2Fs10147-020-01656-3

Publication of results

Published

URL related to results and publications

https://link.springer.com/article/10.1007%2Fs10147-020-01656-3

Number of participants that the trial has enrolled

41

Results

The ORR was 36.6% [95% confidence interval (CI) 22.1-53.1%], median PFS was 9.4 months (95 CI 7.4-17.7 months), and median OS was 24.0 months (95% CI 19.9 months-not reached).

Results date posted

2022

Year

09

Month

25

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2020

Year

05

Month

26

Day

Baseline Characteristics

The median age was 76 years (range 56-90 years), and 51% of patients had a performance status of 0.

Participant flow

Forty-one patients were enrolled and eligible. There were no treatment-related deaths.

Adverse events

The common treatment-related adverse events of grade >= 3 were neutropenia (24%), anorexia (10%), leukopenia (7%), and mucositis/stomatitis (7%).

Outcome measures

The ORR was 36.6% [95% confidence interval (CI) 22.1-53.1%], median PFS was 9.4 months (95 CI 7.4-17.7 months), and median OS was 24.0 months (95% CI 19.9 months-not reached).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2009

Year

01

Month

01

Day

Date of IRB

2009

Year

02

Month

24

Day

Anticipated trial start date

2009

Year

07

Month

21

Day

Last follow-up date

2015

Year

12

Month

23

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2009

Year

07

Month

10

Day

Last modified on

2022

Year

09

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001991