Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607458
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-14
Brief Title:
Evaluation of the Safety and Efficacy of Treatment WHigh Dose Melphalan Given Directly Into the Liver Followed by Treatment Wapproved Cancer Treatment or Approved Cancer Treatment Alone in Patients W Metastatic Colorectal Cancer Wliver Dominant Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Randomized Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment with MelphalanHDS Followed by Consolidation Treatment with Trifluridine-Tipiracil Plus Bevacizumab Versus Trifluridine-Tipiracil Plus Bevacizumab Alone in Patients with Refractory Metastatic Colorectal Cancer with Liver Dominant Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if using a liver-directed therapy with high dose chemotherapy followed by approved cancer treatment to treat patients with colorectal cancer that has spread to the liver is safe and tolerable The clinical trial will also learn if the liver-directed therapy with high dose chemotherapy works on the disease in the liver Investigators will compare the use of the liver-directed therapy with high dose chemotherapy followed by approved cancer treatment or approved cancer treatment alone
Participants will
Undergo up to two liver-directed therapy with high dose chemotherapy procedures followed by approved cancer treatment or take approved cancer treatment alone
Visit clinic at least every two weeks for checkups and tests
Complete scans approximately every two months
Participants will
Undergo up to two liver-directed therapy with high dose chemotherapy procedures followed by approved cancer treatment or take approved cancer treatment alone
Visit clinic at least every two weeks for checkups and tests
Complete scans approximately every two months
Detailed Description:
This is an open-label randomized multi-center study in which patients with liver dominant refractory mCRC will be randomized 21 to receive melphalanHDS 2 cycles followed by trifluridine-tipiracil plus bevacizumab treatment Arm A or trifluridine-tipiracil plus bevacizumab alone Arm B
Approximately 90 patients will be randomized 21 to the two treatment arms Arm A n60 Arm B n30 Patients will receive one of the following treatments
Arm A Patients will be treated with melphalanHDS 30 mgkg ideal body weight IBW for two treatment cycles The second melphalanHDS treatment will be administered 8 weeks after the first treatment with an acceptable delay of up to 2 weeks 10 weeks total to allow for recovery of melphalan-related toxicity if needed Tumor response will be assessed every 8 weeks 3 days during melphalanHDS treatment ie prior to Cycle 2 of melphalanHDS and prior to the start of trifluridine-tipiracil plus bevacizumab treatment
Arm B Patients will be treated with standard regimen of trifluridine-tipiracil and bevacizumab
In both treatment arms treatment with trifluridine-tipiracil plus bevacizumab will continue until disease progression death intolerable adverse events consent withdrawal principal investigator decision or termination of study by Sponsor
Cross-over There will be no cross-over between the two arms of the study Efficacy and Safety Assessment Evaluation of tumor response will be determined by the local principal investigator using RECIST 11 criteria Tumor response evaluation and patient management will be according to the principal investigator assessment of images and patients clinical needs Patients with progressive disease PD will be discontinued from study treatment and will be followed for survival until withdrawal of consent or death
Study treatment will be discontinued if recovery from treatment related toxicity requires more than 2 weeks from the end of the treatment cycle during melphalanHDS cycles Arm A only or more than a 28-day delay in the start of the next cycle of trifluridine-tipiracil plus bevacizumab the end of treatment EOT visit will be conducted at that time or within 4 weeks
Safety will be monitored continuously by documentation of AEs SAEs clinical laboratory measurements vital signs and physical examination
Data Safety Monitoring Board DSMB A DSMB including independent non-investigator clinicians will oversee the emerging patient safety profile during the study The DSMB will review study data on a regular basis according to the DSMB Charter
Approximately 90 patients will be randomized 21 to the two treatment arms Arm A n60 Arm B n30 Patients will receive one of the following treatments
Arm A Patients will be treated with melphalanHDS 30 mgkg ideal body weight IBW for two treatment cycles The second melphalanHDS treatment will be administered 8 weeks after the first treatment with an acceptable delay of up to 2 weeks 10 weeks total to allow for recovery of melphalan-related toxicity if needed Tumor response will be assessed every 8 weeks 3 days during melphalanHDS treatment ie prior to Cycle 2 of melphalanHDS and prior to the start of trifluridine-tipiracil plus bevacizumab treatment
Arm B Patients will be treated with standard regimen of trifluridine-tipiracil and bevacizumab
In both treatment arms treatment with trifluridine-tipiracil plus bevacizumab will continue until disease progression death intolerable adverse events consent withdrawal principal investigator decision or termination of study by Sponsor
Cross-over There will be no cross-over between the two arms of the study Efficacy and Safety Assessment Evaluation of tumor response will be determined by the local principal investigator using RECIST 11 criteria Tumor response evaluation and patient management will be according to the principal investigator assessment of images and patients clinical needs Patients with progressive disease PD will be discontinued from study treatment and will be followed for survival until withdrawal of consent or death
Study treatment will be discontinued if recovery from treatment related toxicity requires more than 2 weeks from the end of the treatment cycle during melphalanHDS cycles Arm A only or more than a 28-day delay in the start of the next cycle of trifluridine-tipiracil plus bevacizumab the end of treatment EOT visit will be conducted at that time or within 4 weeks
Safety will be monitored continuously by documentation of AEs SAEs clinical laboratory measurements vital signs and physical examination
Data Safety Monitoring Board DSMB A DSMB including independent non-investigator clinicians will oversee the emerging patient safety profile during the study The DSMB will review study data on a regular basis according to the DSMB Charter
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