Colorectal Cancer Clinical Trial
Official title:
Phase II Study of Simvastatin Plus Irinotecan, Fluorouracil, and Leucovorin(FOLFIRI) for Metastatic Colorectal Cancer
This trial is designed to assess the tolerability and efficacy of simvastatin plus FOLFIRI (irinotecan, 5-FU, leucovorin) in metastatic colorectal cancer patients.
Progress in treatment for metastatic CRC has undoubtedly been achieved in the past decade.
Until 1985, 5-fluorouracil (5-FU) was the only agent available for the treatment of
metastatic CRC. Several trials have attempted to enhance the activity of bolus 5-FU, by the
addition of levamisole or interferon. Despite of these attempts, no survival advantage was
established until the introduction of the newer cytotoxic drugs. The addition of folinic
acid (FA) to 5-FU, the use of infusional rather than bolus 5-FU, and the combination of new
active agents such as irinotecan and oxaliplatin with 5-FU/FA have resulted in an increase
in activity of 5-FU. In trials of current combination regimens as first-line therapy,
response rates exceeding 30% and median survival duration longer than 16 months have been
reported. In all, despite of rapid advances in the treatment of metastatic CRC during the
last decade, the efficacy of treatment still needs to be improved. One potential way of
increasing the survival of metastatic CRC patients is the introduction of a novel targeting
agent to the standard cytotoxic regimen such as IFL (irinotecan, fluorouracil, and
leucovorin). An increasingly recognized molecular target for anticancer treatment is the
rate-limiting enzyme of the mevalonate pathway, 3-hydroxy-3-methylglutaryl coenzyme A
(HMG-CoA) reductase. The end products of the mevalonate pathway are required for a number of
essential cellular functions such as sterols for membrane integrity, ubiquinone for cell
respiration, geranylgeranyl isoprenoids for covalent bindings to the ras family, dolichol
for glycoprotein synthesis, and isopentenyladenine for tRNA function and protein synthesis.
Fortunately, inhibitors of the key enzyme, the statins, are well established and have been
used safely in the clinic for the treatment of hypercholesterolemia for decades. Therefore,
HMG-CoA reductase may be a decent molecular target for anti-cancer therapy and statins may
be readily applicable to the clinic once its potential role as an anticancer drug is
established. The statins have recently gained attractions from medical oncologists because
large retrospective analyses for efficacy trials of statins in coronary artery disease have
shown that not only are these agents able to reduce cardiac disease-related mortality, but
cancer incidence is also reduced by 28 - 33 %.
In all, further clinical trials investigating on combining the standard treatment with these
novel molecular targeting agents, the statins, are definitely warranted.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |