Pharmacogenomics Study of CPT-11 as the First-line Chemot... | NCT01282658

Studies
Pharmacogenomics Study of CPT-11 as the First-line Chemotherapy for mCRC

NCT01282658

Sponsor

Huazhong University of Science and Technology

Status

Unknown status

Last Update Posted

Feb 17, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2010

Primary Completion Date

Dec 2012Estimated

Completion Date

May 2013Estimated

First Submitted Date

Jan 24, 2011

First Submission Date that Met QC Criteria

Jan 24, 2011

First Posted Date

Jan 25, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2011

Last Update Posted Date

Feb 17, 2011Estimated

Name	Class
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	OTHER
Wuhan University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Irinotecan (CPT-11) is now widely used as the first-line chemotherapy for mCRC. There were 4 key enzymes for CPT-11 metabolizing, CYP3A4, UDP-glucuronosyltransferase, carboxylesterase(CES), and ATP-binding cassette (ABC) transporters. Genetic variations of those enzymes may cause the heterogeneity in safety and efficacy of CPT-11. The aim of this study is to figure out the correlation between the genetic polymorphism and the drug response.

Detailed Description

collect blood samples,determining genetic contribution to the safety and efficacy of CPT-11.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Colorectal cancer

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed colorectal cancer
≥ 18 years old
Measurable disease, defined as to RECIST criteria
Unresectable metastatic disease OR First recurrence/metastasis after adjuvant therapy and not suitable for operation
FOLFIRI±cetuximab/bevacizumab as the first-line therapy
Without expected course of radiotherapy during the first-line chemotherapy
No previous CPT-11 chemotherapy
ECOG performance status (PS) 0-2
Not pregnant or nursing and Negative pregnancy test
Voluntarily signed the informed consent
Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if f liver metastases present)
Creatinine clearance > 50 mL/min OR serum creatinine ≤ 1.5 times ULN

Exclusion Criteria:

Brain metastases with obvious symptoms
Severe bone marrow failure and can not be corrected
Chronic diarrhea history
Bowel obstruction without control
Mental illness without control
Clinically significant (i.e., active) cardiovascular disease, including any of the following: Cerebrovascular accidents/ Myocardial infarction/ Unstable angina/ New York Heart Association class II-IV congestive heart failure/ Serious cardiac arrhythmia requiring medication/ Uncontrolled hypertension
Other co-existing malignancy or malignancy diagnosed within the past 5 years, except for basal cell or squamous cell carcinoma, or carcinoma in situ of the cervix
Pelvic radiotherapy for the past 1 year
Known allergy to any of the components of the study medications
Serious, nonhealing wound or ulcer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

primary care clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yuan X Lin, PHD	Contact	0086-02783663342		yxl@medmail.com.cn
huang liu, MD	Contact	0086-02783663514		huangliu017@163.com

Overall Officials

Name	Affiliation	Role
Yuan X Lin, PHD	Tongji Hospital of Tongji Medical College, Hua Zhong University of Science & Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tongji Hospital of Tongji Medical College, Hua Zhong University of Science & Technology	Recruiting	Wuhan	Hubei	430030	China

References Module

Citations

PubMed Identifier	Type	Citation
16904315	Background	Van Cutsem E, Nordlinger B, Adam R, Kohne CH, Pozzo C, Poston G, Ychou M, Rougier P; European Colorectal Metastases Treatment Group. Towards a pan-European consensus on the treatment of patients with colorectal liver metastases. Eur J Cancer. 2006 Sep;42(14):2212-21. doi: 10.1016/j.ejca.2006.04.012. Epub 2006 Aug 10.
	Background	A Report of Cancer Incidence and Mortality from 34 Cancer Registries in China，2006. China Cancer 19:356-65, 2010
17026789

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site