UMIN-CTR Clinical Trial

Public title

Phase 1 study of cisplatin + sulfasalazine in patients with advanced gastric cancer.

Acronym

CDDP+SASP

Scientific Title

Phase 1 study of cisplatin + sulfasalazine in patients with advanced gastric cancer.

Scientific Title:Acronym

CDDP+SASP

Region

Japan

Condition

advanced gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To determine a recommend dose of CDDP+SASP in CD44v positive patients with advanced gastric cancer.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Frequency of dose limiting toxicity (DLT)

Key secondary outcomes

Adverse event : AE
Response rate: RR
Progression free survival: PFS

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

CDDP 60mg/m2 is administrated on day1 and SAPS 6 g /day are orally-administered daily in day 1-14. The maximum dose is 8 g a day.
1 cycle is 21days until progressive disease.

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 or cytologically proven gastric adenocarcinoma or gastro-esophageal junction adenocarcinoma.
2)Archival tumor specimen with CD44v positive before this therapy, and biopsy specimens are considered to be available before and after 1 course of this therapy.
3)Disease progression during or within 3 months after prior chemotherapy including cisplatin
4)>= 20 years old.
5)ECOG Performance Status of 0-1, or 2.
6)Adequate organ function. i.e. meet all criterion as follows.
Absolute neutrophil count>=1,500 /mm3
Hemoglobin >=8.0 g/dL
Platelet count>=75,000 /mm3
Total bilirubin <= 2.0 mg/dL
AST<=100 IU/L or <=150 IU/L with liver metastasis.
ALT<=100 IU/L or <=150 IU/L with liver metastasis.
Serum creatinine<=2.0 mg/dL or Creatinine clearance >=50 mL/min
7)No blood transfusion within 8 days prior to enrollment.
8)AE related to prior treatment must be Grade <= 1 according to CTCAE. (except alopecia, peripheral sensory neuropathy, skin hyperpigmentation and dysgeusia)
9)Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to enrollment.
10)Adequate oral intake.
11)Written informed consent.

Key exclusion criteria

1)Chemotherapy, radiation therapy or other investigational drugs within 2 weeks prior to enrollment.
2)Active bleeding.
3)Patient with any of the following symptoms within 6 months prior to administration of the drug;myocardial infarction, severe or unstable angina, congested heart failure,cerebrovascular accident containing transient ischemic attack or pulmonary embolism.
4)Uncontrolled bronchial asthma.
5)Patient with brain metastases.
6)Laparotomy or thoracotomy within 4 weeks to enrollment.
7)Known hypersensitivity to sulfa drugs or acetylsalicylic acid formulation.
8)Known history of serious adverse events due to cisplatin
9)Women during pregnancy or lactation, women suspected of being pregnant, women desiring future fertility.
10)Patient is judged by the investigator to be inappropriate for study participation for any reason.
11)Patient with Ulcerative colitis, or treated patient with sulfapyridine or 5-ASA derivative.

Target sample size

18

Name of lead principal investigator

1st name
Middle name
Last name	Toshihiko Doi

Organization

National Cancer Center Hospital East

Division name

Gastrointestinal Oncology Division

Zip code

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

TEL

04-7133-1111

Email

sasp_core@east.ncc.go.jp

Name of contact person

1st name
Middle name
Last name	Kohei Shitara

Organization

National Cancer Center Hospital East

Division name

Gastrointestinal Oncology Division

Zip code

Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan

TEL

04-7133-1111

Homepage URL

Email

sasp_core@east.ncc.go.jp

Institute

National Cancer Center Hospital East

Institute

Department

Personal name

Organization

Health and Labor Sciences Research Grant

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

School of Medicine, Keio University

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

国立がん研究センター東病院

Date of disclosure of the study information

2014

Year

11

Month

04

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

2014

Year

09

Month

28

Day

Date of IRB

Anticipated trial start date

2014

Year

11

Month

15

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

11

Month

04

Day

Last modified on

2016

Year

04

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017850