Ignite Creation Date:
2024-05-06 @ 7:17 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02508077
Status:
TERMINATED
Last Update Posted:
2018-08-16
First Post:
2015-07-22
Brief Title:
FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Prospective Study of FOLFIRI Plus Panitumumab in Extended RAS Wild Type and BRAF Wild Type Metastatic Colorectal Cancer With Acquired Resistance to Prior Cetuximab or Panitumumab Plus Irinotecan-Based Therapy and Who Failed at Least One Subsequent Non-anti-EGFR Containing Regimen
Status:
TERMINATED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well fluorouracil leucovorin calcium and irinotecan hydrochloride FOLFIRI together with panitumumab work in treating patients with colorectal cancer that expresses the RAS and B-Raf proto-oncogene serinethreonine kinase BRAF wild-type genes has spread from the original site of growth to another part of the body metastatic resists the effects of treatment with prior cetuximab or panitumumab plus irinotecan hydrochloride-based therapy and who have failed at least one subsequent non-anti-epidermal growth factor receptor EGFR containing treatment regimen Drugs used in chemotherapy such as fluorouracil leucovorin calcium and irinotecan hydrochloride work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Giving more than one drug combination chemotherapy may kill more tumor cells Monoclonal antibodies such as panitumumab may block tumor growth in different ways by targeting certain cells Giving FOLFIRI together with panitumumab may be an effective treatment for colorectal cancer
Detailed Description:
PRIMARY OBJECTIVES
I Estimate the response rate RR and progression-free survival PFS with FOLFIRI panitumumab in patients with acquired resistance to panitumumab or cetuximab irinotecan irinotecan hydrochloride-based therapy after a documented clinical response or prolonged PFS and following progression on a subsequent non-anti-EGFR containing regimen in extended RAS wild-type and BRAF wild-type patients
SECONDARY OBJECTIVES
I Estimate the overall survival OS in the re-challenge populations
II Describe the safety of re-challenge in this population
III Investigate the impact of PFS RR on prior anti-EGFR irinotecan-based exposure on the response and PFS on the current study
TERTIARY OBJECTIVES
I Collect serial plasma samples to investigate the incidence of RAS and BRAF mutation in circulating free deoxyribonucleic acid DNA at baseline every 2 months and at the time to progression and following progression when feasible
II Collect serial plasma samples for future biomarker exploration including the potential investigation of micro-ribonucleic acid RNA
OUTLINE
Patients receive panitumumab intravenously IV over 30-90 minutes irinotecan hydrochloride IV over 90 minutes leucovorin calcium orally PO and fluorouracil IV over 46 hours on day 1 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then every 3 months thereafter
I Estimate the response rate RR and progression-free survival PFS with FOLFIRI panitumumab in patients with acquired resistance to panitumumab or cetuximab irinotecan irinotecan hydrochloride-based therapy after a documented clinical response or prolonged PFS and following progression on a subsequent non-anti-EGFR containing regimen in extended RAS wild-type and BRAF wild-type patients
SECONDARY OBJECTIVES
I Estimate the overall survival OS in the re-challenge populations
II Describe the safety of re-challenge in this population
III Investigate the impact of PFS RR on prior anti-EGFR irinotecan-based exposure on the response and PFS on the current study
TERTIARY OBJECTIVES
I Collect serial plasma samples to investigate the incidence of RAS and BRAF mutation in circulating free deoxyribonucleic acid DNA at baseline every 2 months and at the time to progression and following progression when feasible
II Collect serial plasma samples for future biomarker exploration including the potential investigation of micro-ribonucleic acid RNA
OUTLINE
Patients receive panitumumab intravenously IV over 30-90 minutes irinotecan hydrochloride IV over 90 minutes leucovorin calcium orally PO and fluorouracil IV over 46 hours on day 1 Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days and then every 3 months thereafter
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 |
|---|---|---|---|
| 15117 | OTHER | City of Hope Comprehensive Cancer Center | None |
| NCI-2015-01241 | REGISTRY | None | None |
| 118713 | None | None | None |