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A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers, GITIC Study (GITIC)

Primary Purpose

Gastrointestinal Cancers

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Erlotinib or Gefitinib
Everolimus
Imatinib
Sorafenib or Sunitinib
Vandetanib
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Cancers focused on measuring genomic sequencing, Integrated genomic network analysis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pathologic diagnosis of Gastrointestinal cancer
  2. The subject has a diagnosis metastatic gastrointestinal cancer, and failed from standard treatment, and no other regimen is available.
  3. The subject has measurable lesion of gastrointestinal cancer.
  4. The subject's The Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  5. The subject has adequate hematologic function as defined by an absolute neutrophil count (ANC) >/= 1,500/mm3, platelet count >/= 100,000/mm3, White Blood Count (WBC) >/= 3,000/ mm3, and hemoglobin >/= 9 g/dL.
  6. The subject has adequate hepatic function as defined by a total bilirubin level </= 1.5 * the upper limit of normal (ULN) (bilirubin >/= 1.5 * ULN with known Gilbert's disease is allowed), and alkaline phosphatase, aspartate aminotransferase/alanine aminotransferase (AST/ALT) </= 2.5 * the upper limit of normal or </= 5.0 * ULN if liver metastases are present.
  7. Serum creatinine clearance >50ml/min, either by Cockcroft-Gault formula or 24-hour urine collection analysis
  8. The subject is >/=18 years of age.
  9. The subject has signed informed consent.
  10. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation, hysterectomy or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

  1. pregnant or breast-feeding.
  2. Subjects will be excluded for other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study
  3. without enough tumor sample for analysis.
  4. Refuse to sign the informed consent.

Sites / Locations

  • Gastrointestinal Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

Erlotinib or Gefitinib

Everolimus

Imatinib

Sorafenib or Sunitinib

Vandetanib

Control

Arm Description

Erlotinib 150 mg tablet or Gefitinib 250 mg tablet by mouth every day

Everolimus 10 mg orally once daily every day

Imatinib 400 mg tablet orally per day

Sorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day

Vandetanib 300 mg orally once daily

No intervention was performed for patients without any gene alternation or without any available target agents

Outcomes

Primary Outcome Measures

Overall survival
From the date of enrollment until the date of death from any cause.

Secondary Outcome Measures

Response rate
After identifying the driver gene and choosing the specific target drug, the response rate of all patients.

Full Information

First Posted
December 11, 2013
Last Updated
August 27, 2016
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02013089
Brief Title
A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers, GITIC Study
Acronym
GITIC
Official Title
A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypothesis: Different patients have different biomarkers, if doctors know about the biomarkers of patients; they may be able to prescribe a regimen that is better suited to the patient's specific needs. This is a pilot study. Here, we used whole exon sequencing and Integrated genomic network analysis to identify the biomarker or gene. We aimed to learn if the drug chosen based on biomarkers can help to control metastatic gastrointestinal cancer who had failed from all standard and available regimens.
Detailed Description
Rational: Cancer sequencing (CS) promises to become the centerpiece of personalized oncology by informing on treatments targeted to each tumor's unique genetic constitution. This data can be critical to making an informed decision for disease management, though this may not be the case for all patients. CS identifies variations or differences in the DNA and/or RNA of the cells in an individual's tumor by comparison to that of his/her normal cells. These somatic variations may, on further interpretation, be identified as key drivers of carcinogenesis. Such information may predict a patient's prognosis, response to currently available treatments or prompt the development of novel therapeutics. Though CS has the potential to personalize and optimize cancer care, it may produce a vast amount of data and unique changes in the DNA/RNA that may be difficult to interpret at the present time. Using the Integrated genomic network analysis, we could have better understanding of the underlying processes and pathways involved in tumor onset and progression. And then we could choose a specific treatment regimen and develop personalized cancer therapies

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancers
Keywords
genomic sequencing, Integrated genomic network analysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Erlotinib or Gefitinib
Arm Type
Experimental
Arm Description
Erlotinib 150 mg tablet or Gefitinib 250 mg tablet by mouth every day
Arm Title
Everolimus
Arm Type
Experimental
Arm Description
Everolimus 10 mg orally once daily every day
Arm Title
Imatinib
Arm Type
Experimental
Arm Description
Imatinib 400 mg tablet orally per day
Arm Title
Sorafenib or Sunitinib
Arm Type
Experimental
Arm Description
Sorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day
Arm Title
Vandetanib
Arm Type
Experimental
Arm Description
Vandetanib 300 mg orally once daily
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention was performed for patients without any gene alternation or without any available target agents
Intervention Type
Drug
Intervention Name(s)
Erlotinib or Gefitinib
Other Intervention Name(s)
Erlotinib (Tarceva®) or Gefitinib (Iressa®)
Intervention Description
Erlotinib 150mg talbet or Gefitinib 250 mg tablet per day for patients with EGFR gene alternation
Intervention Type
Drug
Intervention Name(s)
Everolimus
Other Intervention Name(s)
Afinitor®
Intervention Description
Everolimus 10 mg orally once daily every day for patients with mTOR gene alternation
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
Gleevec®
Intervention Description
Imatinib 400 mg tablet orally per day for patietns with KIT, PDGFR, ABL gene alternation
Intervention Type
Drug
Intervention Name(s)
Sorafenib or Sunitinib
Other Intervention Name(s)
Sorafenib (Nexavar®) Sunitinib (Sutent®)
Intervention Description
Sorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day with or without food for patients with VEGFR, KIT, RAF gene alternation
Intervention Type
Drug
Intervention Name(s)
Vandetanib
Other Intervention Name(s)
Caprelsa®
Intervention Description
Vandetanib 300 mg orally once daily for patients with RET gene fusion.
Primary Outcome Measure Information:
Title
Overall survival
Description
From the date of enrollment until the date of death from any cause.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Response rate
Description
After identifying the driver gene and choosing the specific target drug, the response rate of all patients.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Disease control rate
Description
The disease control rate of all patients.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologic diagnosis of Gastrointestinal cancer The subject has a diagnosis metastatic gastrointestinal cancer, and failed from standard treatment, and no other regimen is available. The subject has measurable lesion of gastrointestinal cancer. The subject's The Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. The subject has adequate hematologic function as defined by an absolute neutrophil count (ANC) >/= 1,500/mm3, platelet count >/= 100,000/mm3, White Blood Count (WBC) >/= 3,000/ mm3, and hemoglobin >/= 9 g/dL. The subject has adequate hepatic function as defined by a total bilirubin level </= 1.5 * the upper limit of normal (ULN) (bilirubin >/= 1.5 * ULN with known Gilbert's disease is allowed), and alkaline phosphatase, aspartate aminotransferase/alanine aminotransferase (AST/ALT) </= 2.5 * the upper limit of normal or </= 5.0 * ULN if liver metastases are present. Serum creatinine clearance >50ml/min, either by Cockcroft-Gault formula or 24-hour urine collection analysis The subject is >/=18 years of age. The subject has signed informed consent. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months, who have not had tubal ligation, hysterectomy or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately. Exclusion Criteria: pregnant or breast-feeding. Subjects will be excluded for other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study without enough tumor sample for analysis. Refuse to sign the informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanghong Deng, PhD
Organizational Affiliation
Sixth Affiliated Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gastrointestinal Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yanghong Deng, PhD
Phone
008613925106525
Email
13925106525@163.com
First Name & Middle Initial & Last Name & Degree
Yanhong Deng, PhD

12. IPD Sharing Statement

Learn more about this trial

A Pilot Study of Genomic Sequencing Guided Individualized Therapy in Gastrointestinal Cancers, GITIC Study

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