UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003176
Receipt number R000003851
Scientific Title Phase I study of a combination of capecitabine plus CPT-11 (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy
Date of disclosure of the study information 2010/02/12
Last modified on 2017/02/21 18:23:22

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Basic information

Public title

Phase I study of a combination of capecitabine plus CPT-11 (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy

Acronym

Phase I study of a combination of capecitabine plus CPT-11 (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy

Scientific Title

Phase I study of a combination of capecitabine plus CPT-11 (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy

Scientific Title:Acronym

Phase I study of a combination of capecitabine plus CPT-11 (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy

Region

Japan


Condition

Condition

Colorectal cancer

Classification by specialty

Gastroenterology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the feasibility of the combination of capecitabine plus irinotecan (CC therapy) in patients with metastatic colon cancer refractory to oxaliplatin containing chemotherapy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Dose limiting toxicity, safety

Key secondary outcomes

Response rate, overall survival, progression free survival, disease control rate


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

CPT-11 150mg/m2(day1)
Capecitabine Xmg/m2, p.o.(day2-8)
to be repeated every 2 weeks for four course

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1. histologically proven colon or rectum cancer
2. Patients with tumor resistant to oxaliplatin after one or more courses of oxaliplatin treatment
3. Written informed consent
4. Age: 20-75 yo
5. Performance status: 0-2 (ECOG criteria)
6. A predicted life expectancy of at least 3 months.
7. With prior chemotherapy completed before more than 14 days
8. with sufficient bone marrow, renal or hepatic function
WBC: 3,000 /mm3 <= and =< 12,000/mm3
Neutrocyte: 1,500/mm3=<
Platelet: 100,000/mm3 =<
Hemoglobin: 8.0 g/dl =<
Total bilirubin: 1.5 >=
GOT, GPT: 100 >
Creatinine: 1.2mg/dl =>
Creatinine clearance : 60 <=
9. Ability of oral intake

Key exclusion criteria

1) with treatments including CPT-11
2) with active double cancers
3) Any other serious illness or medical condition(s) including ileus, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, heart failure, renal failure, liver failure, etc.
4) Infectious disease
5) Diarrhea (watery stools)
6) with obstruction or disorder on digestive tract due to peritoneal metastasis
7) with ascites and/or pleural fluid
8) History of serious drug hypersensitivity
9) Undergoing anti-fungal treatment with fluorocytosine, or atazanavir sulfate.
10) Found to have fresh gastrointestinal bleeding that requires repeated transfusion.
11) With liver cirrhosis or jaundice.
12) patients undergoing treatment with a psychotropic agent or who have a mental disorder that seems to require treatment.
13) having heart disease, such as ischemic heart disease or an arrhythmia, which require treatment.
14) With diabetes that is difficult to control.
15) With central nervous system metastasis
16) Patients with UGT1A1 genotype *6/*6, *28/*28 and *6/*28
17) women pregnant, breast-feeding, or who wish pregnancy
18) Any other patient whom the physician in charge of the study judges to be unsuitable

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naotoshi Sugimoto

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Medical Oncology

Zip code


Address

1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Naotoshi Sugimoto

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Medical Oncology

Zip code


Address

1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases

Institute

Department

Personal name



Funding Source

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2010 Year 02 Month 12 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 01 Month 14 Day

Date of IRB


Anticipated trial start date

2010 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 02 Month 12 Day

Last modified on

2017 Year 02 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003851


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name