Ignite Creation Date:
2024-05-05 @ 11:13 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01280643
Status:
TERMINATED
Last Update Posted:
2021-03-15
First Post:
2011-01-20
Brief Title:
Combination Chemotherapy and Cetuximab or Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Fox Chase Cancer Center
Organization:
Fox Chase Cancer Center
Study Overview
Official Title:
An Exploratory Study of Chemotherapy for Metastatic Colorectal Cancer Based Upon Thymidine Phosphorylase Expression KRAS and BRAF Mutation Status and ERCC1 Expression
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as fluorouracil leucovorin calcium oxaliplatin capecitabine and irinotecan hydrochloride work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy and giving the drugs in different combinations may kill more tumor cells Monoclonal antibodies such as bevacizumab and cetuximab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Giving combination chemotherapy together with bevacizumab or cetuximab may kill more tumor cells
PURPOSETo evaluate the use of standard KRAS and experimental thymidine phosphorylase ERCC1 and BRAF tumor testing can aid in selecting chemotherapy regimens
PURPOSETo evaluate the use of standard KRAS and experimental thymidine phosphorylase ERCC1 and BRAF tumor testing can aid in selecting chemotherapy regimens
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the feasibility as defined by completion of three specific marker assays and generation of clinically meaningful endpoints of selecting treatment regimen components based on biologic tumor characteristics in chemotherapy-naïve patients with metastatic colorectal cancer
SECONDARY OBJECTIVES
I To investigate the response rate associated with genotypephenotype guided therapy using Response Evaluation Criteria in Solid Tumors RECIST version 11
II To investigate the time to failure of treatment strategy associated with genotypephenotype guided therapy defined as the time from initiation of investigational treatment strategy until death disease progression initiation of a new therapeutic agent or disease progression while on a partial or complete treatment holiday
III To investigate the progression-free survival associated with genotypephenotype guided therapy defined as the time from enrollment to time of progression of disease or death
OUTLINE Patients are assigned to treatment groups based on marker assay results
ARM A TP-uncertain KRAS and BRAF wild-type ERCC1 high ARM B TP-uncertain KRAS and BRAF wild-type ERCC1 lowuncertain ARM C TP-uncertain KRAS or BRAF mutantuncertain ERCC1 high ARM D TP-uncertain KRAS or BRAF mutantuncertain ERCC1 lowuncertain ARM E TP KRAS and BRAF wild-type ERCC1 high ARM F TP KRAS and BRAF wild-type ERCC1 lowuncertain ARM G TP KRAS or BRAF mutantuncertain ERCC1 high ARM H TP KRAS or BRAF mutantuncertain ERCC1 lowuncertain ARM I TP uninterpretable KRAS or BRAF uninterpretable ERCC1 uninterpretable
KRAS testing is standard of care in patients with metastatic colorectal cancer tymidine phosphorylase ERCC1 and BRAF testing assays are still experimental
Courses in arms A-D and arm I repeat every 28 days and courses in arms E-H repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 18 months
I To evaluate the feasibility as defined by completion of three specific marker assays and generation of clinically meaningful endpoints of selecting treatment regimen components based on biologic tumor characteristics in chemotherapy-naïve patients with metastatic colorectal cancer
SECONDARY OBJECTIVES
I To investigate the response rate associated with genotypephenotype guided therapy using Response Evaluation Criteria in Solid Tumors RECIST version 11
II To investigate the time to failure of treatment strategy associated with genotypephenotype guided therapy defined as the time from initiation of investigational treatment strategy until death disease progression initiation of a new therapeutic agent or disease progression while on a partial or complete treatment holiday
III To investigate the progression-free survival associated with genotypephenotype guided therapy defined as the time from enrollment to time of progression of disease or death
OUTLINE Patients are assigned to treatment groups based on marker assay results
ARM A TP-uncertain KRAS and BRAF wild-type ERCC1 high ARM B TP-uncertain KRAS and BRAF wild-type ERCC1 lowuncertain ARM C TP-uncertain KRAS or BRAF mutantuncertain ERCC1 high ARM D TP-uncertain KRAS or BRAF mutantuncertain ERCC1 lowuncertain ARM E TP KRAS and BRAF wild-type ERCC1 high ARM F TP KRAS and BRAF wild-type ERCC1 lowuncertain ARM G TP KRAS or BRAF mutantuncertain ERCC1 high ARM H TP KRAS or BRAF mutantuncertain ERCC1 lowuncertain ARM I TP uninterpretable KRAS or BRAF uninterpretable ERCC1 uninterpretable
KRAS testing is standard of care in patients with metastatic colorectal cancer tymidine phosphorylase ERCC1 and BRAF testing assays are still experimental
Courses in arms A-D and arm I repeat every 28 days and courses in arms E-H repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 18 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-00046 | REGISTRY | CTRP Clinical Trial Reporting Program | None |