Impact of Regorafenib in Combination With Multimodal Metronomic Chemotherapy on Progression-free Survival Compared With Standard Regorafenib for the Treatment of Chemo-resistant Metastatic Colorectal Cancers

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Procedure, Combination product, Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The main objective is to evaluate the impact of a Regorafenib combined with metronomic chemotherapy (capecitabine and cyclophosphamide) and low-dose aspirin compared to standard Regorafenib treatment in patients with metastatic colorectal cancer by assessing progression-free survival.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with histologically proven metastatic colorectal cancer in progression after previous standard treatments (5FU, CPT11 (Irinotecan), oxaliplatin, anti-VEGF (vascular endothelial growth factor), trifluridine/tipiracil, anti-EGFR (epidermal growth factor receptor) therapy if KRAS (Kirsten rat sarcoma) and NRAS WT (wild type), anti-BRAF therapy if BRAF V600E mutated, and anti-PD1 (Programmed Death-1) if MSI-H (microsatellite instability) /dMMR (deficient MisMatch Repair) tumor, or not considered as candidate for these treatments.

• Life expectancy of at least 3 months

• Female or male with age \>18 years old

• Performance status = 0 or 1 (Annex 1)

• Measurable disease defined according to RECIST v1.1 guidelines (scanner or MRI)

• Adequate bone marrow, liver and renal functions.

∙ Haemoglobin ≥ 9 g/dL; absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L

‣ Total serum bilirubin ≤ 1.5 times upper normal value (ULN), serum alkaline phosphatase \< 5 times ULN, aminotransferases (AST/ALT) ≤ 3 × ULN in absence of hepatic metastasis or ≤ 5 if presence of hepatic lesions

‣ Cockcroft glomerular filtration rate \> 50 ml/min

‣ Proteinuria \<2+ (dipstick urinalysis) or ≤1g/24hour

• No contraindication to Iodine contrast media injection during CT

• For female patients of childbearing potential, negative pregnancy test within 14 days before starting the study drug. Men and women are required to use adequate birth control during the study (when applicable),

• Signed and dated informed consent,

⁃ Ability to comply with the study protocol, in the Investigator's judgment.

⁃ Registration in a national health care system (CMU included).

Locations
Other Locations
France
CHU d'Auxerre
RECRUITING
Auxerre
Centre Hospitalier Universitaire de Besançon
RECRUITING
Besançon
CH de Colmar
RECRUITING
Colmar
Centre Georges-François Leclerc (CGFL)
RECRUITING
Dijon
Hôpital Robert Schuman
RECRUITING
Metz
Hôpital Nord Franche-Comté
RECRUITING
Montbéliard
CHU de Montpellier
RECRUITING
Montpellier
CHU de Reims - Hôpital Robert Debré
RECRUITING
Reims
Clinique Privée de Strasbourg
NOT_YET_RECRUITING
Strasbourg
ICANS
RECRUITING
Strasbourg
Contact Information
Primary
Angélique VIENOT, Dr
a3vienot@chu-besancon.fr
+33 370632278
Backup
Christophe BORG, Pr
xtoph.borg@gmail.com
Time Frame
Start Date: 2024-07-19
Estimated Completion Date: 2028-09
Participants
Target number of participants: 174
Treatments
Active_comparator: Regorafenib
• Regorafenib will be administered 3 weeks out of 4 (1 cycle corresponding to 4 weeks) until progression or unacceptable toxicity.~For the first cycle: Regorafenib will be administered according to the REDOS schedule week 1: 80 mg regorafenib daily week 2: 120 mg regorafenib daily week 3: 160 mg regorafenib daily week 4 : no regorafenib~For the following cycles: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle.
Experimental: Regorafenib+ metronomic chemotherapy + aspirin
• Regorafenib will be administered 3 weeks out of 4 (1 cycle corresponding to 4 weeks) until progression or unacceptable toxicity.~For the first cycle: Regorafenib will be administered according to the REDOS schedule: week 1: 80 mg daily week 2: 120 mg daily week 3: 160 mg daily week 4 : OFF. For the following cycles: regorafenib will be administered at 160mg in the absence of significant toxicity during cycle 1 or at a 80/120mg daily dose according to toxicity observed with the last dose used in the first cycle.~* Metronomic chemotherapy will be administrated as following:Cyclophosphamide: 50 mg per os, daily, for 6 months,Capecitabine: 625mg/m²/orally twice daily, for 6 months.~* Low-dose Aspirin: 75 mg orally, daily, until progression.
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Besancon
Collaborators: Groupement Interrégional de Recherche Clinique et d'Innovation

This content was sourced from clinicaltrials.gov