Stage IV Colorectal Cancer AJCC v8 Clinical Trial
Official title:
A Phase I Study of Riluzole in Combination With mFOLFOX6/Bevacizumab in Patients With Metastatic Colorectal Cancer
This phase I trial is to find out the best dose, possible benefits, and/or side effects of riluzole and how well it works in combination with standard of care mFOLFOX6 and bevacizumab in treating patients with colorectal cancer that has spread to other places in the body (metastatic). Riluzole is a well-tolerated oral medication that has demonstrated it may make chemotherapy work better. Chemotherapy drugs, such as oxaliplatin, leucovorin calcium and fluorouracil, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab is an antibody that targets the blood vessel by blocking the activity of a protein called vascular endothelial growth factor alpha (VEGF-A). It helps to make the mFOLFOX6 more effective. Giving riluzole, mFOLFOX6, and bevacizumab may kill more tumor cells compared to mFOLFOX6 and bevacizumab alone in treating patients with colorectal cancer.
PRIMARY OBJECTIVE: I. Characterize the safety and toxicity of riluzole in combination with modified (m) leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX) 6/bevacizumab and determine the recommended phase II dose (RP2D) of riluzole in combination with mFOLFOX6/bevacizumab in patients with metastatic colorectal cancer. SECONDARY OBJECTIVE: I. Determine the pharmacokinetics of riluzole in patients with metastatic CRC. EXPLORATORY OBJECTIVES: I. Assess the efficacy of the combination treatment. II. Determine the effect of riluzole in downstream GRM3 signaling by immunofluorescent staining of phosphorylated (p)AKT and pCREB in pre- and post-treatment tumor tissues. III. Assess FCGRT/FcRn expression, bevacizumab pharmacokinetics, inflammatory cytokines, and cachexia associated factors as early biomarkers for resistance to therapy. IV. Assess cytotoxic T cells in peripheral blood to evaluate the immunomodulatory effect of this therapy. OUTLINE: This is a dose-escalation study of riluzole. Patients receive riluzole orally (PO) twice daily (BID) on days 1-14. Patients also receive oxaliplatin via intravenous piggyback (IVPB) over 2 hours, leucovorin calcium IVPB over 2 hours, and bevacizumab IVPB over 30 minutes on day 1 and fluorouracil via intravenous (IV) push over 5 minutes and then IV continuously over 46 hours on days 1-2. Treatment repeats every 2 weeks for up to 8 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05691491 -
Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness
|
Phase 1/Phase 2 | |
| Terminated |
NCT04832763 -
Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer
|
N/A | |
| Active, not recruiting |
NCT04164069 -
Dasatinib for the Prevention of Oxaliplatin-Induced Neuropathy in Patients With Metastatic Gastrointestinal Cancer Receiving FOLFOX Chemotherapy With or Without Bevacizumab
|
Phase 1 | |
| Active, not recruiting |
NCT03981614 -
Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer
|
Phase 2 | |
| Recruiting |
NCT05863195 -
Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial
|
Phase 3 | |
| Active, not recruiting |
NCT03983993 -
Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer
|
Phase 2 | |
| Completed |
NCT04597151 -
Diet Education Program for Stage I-IV Colorectal Cancer Survivors
|
N/A | |
| Not yet recruiting |
NCT05518032 -
Pembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC)
|
Phase 2 | |
| Recruiting |
NCT05803382 -
Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers
|
Phase 1 | |
| Not yet recruiting |
NCT05356897 -
Tucatinib Combined With Trastuzumab and TAS-102 for the Treatment of HER2 Positive Metastatic Colorectal Cancer in Molecularly Selected Patients, 3T Study
|
Phase 2 | |
| Recruiting |
NCT06102902 -
Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer
|
Phase 1 | |
| Recruiting |
NCT04314401 -
National Cancer Institute "Cancer Moonshot Biobank"
|
||
| Suspended |
NCT04111172 -
A Vaccine (Ad5.F35-hGCC-PADRE) for the Treatment of Gastrointestinal Adenocarcinoma
|
Phase 2 | |
| Recruiting |
NCT05627635 -
FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04362839 -
Regorafenib, Ipilimumab and Nivolumab for the Treatment of Chemotherapy Resistant Microsatellite Stable Metastatic Colorectal Cancer
|
Phase 1 | |
| Recruiting |
NCT05672316 -
Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05733000 -
CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Treating Patients With Advanced Chemorefractory Solid Tumors
|
Phase 2 | |
| Active, not recruiting |
NCT04117945 -
Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02983578 -
Danvatirsen and Durvalumab in Treating Patients With Advanced and Refractory Pancreatic, Non-Small Cell Lung Cancer, and Mismatch Repair Deficient Colorectal Cancer
|
Phase 2 | |
| Recruiting |
NCT04693377 -
Cryoablation Combined With Stereotactic Body Radiation Therapy for the Treatment of Painful Bone Metastases, the CROME Trial
|
N/A |