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

Gastrointestinal Cancers Clinical Trial

— GITIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02013089
• Other study ID #: GIHSYSU04
• Status: Recruiting
• Phase: N/A
• First received: December 11, 2013
• Last updated: August 27, 2016
• Start date: December 2013
• Est. completion date: December 2017

Study information

• Verified date: August 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Cancers
• Gastrointestinal Neoplasms

Intervention

Drug:
• Erlotinib or Gefitinib
Erlotinib 150mg talbet or Gefitinib 250 mg tablet per day for patients with EGFR gene alternation
• Everolimus
Everolimus 10 mg orally once daily every day for patients with mTOR gene alternation
• Imatinib
Imatinib 400 mg tablet orally per day for patietns with KIT, PDGFR, ABL gene alternation
• Sorafenib or Sunitinib
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
• Vandetanib
Vandetanib 300 mg orally once daily for patients with RET gene fusion.

Locations

Country	Name	City	State
China	Gastrointestinal Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease control rate	The disease control rate of all patients.	1 year	No
Primary	Overall survival	From the date of enrollment until the date of death from any cause.	1 year	Yes
Secondary	Response rate	After identifying the driver gene and choosing the specific target drug, the response rate of all patients.	1 year	No