TRIFLUOX-DP: Safety of Trifluridine/Tipiracil as Replacement of Fluoropyrimidines (5-fluorouracil and Capecitabine) Based Chemotherapy as First Line Metastatic Colorectal or Gastroesophageal Cancer Regimens in Patients With Dihydropyrimidine Dehydrogenase Deficiency: a Phase II Trial

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this clinical trial is to test the safety of the trifluridine/tipiracil as replacement of fluoropyrimidines based chemotherapy as first line metastatic colorectal or gastroesophageal cancer regimens in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. The main questions it aims to answer are: * Is this alternative chemotherapy option a better option in term of safety for this type of patients? * Does the combination of treatments improves the overall safety? * Does the combination of treatments improves the progression-free survival, overall survival, objective response rate and disease control rate? * Does the combination of treatment have an effect on quality of life? Participants will: * Receive the trifluridine/tipiracil with oxaliplatin every 14 days, associated with: * Panitumumab or bevacizumab for colorectal adenocarcinomas * Nivolumab or trastuzumab for gastroesophageal adenocarcinomas. * Have a CT-Scan every 2 months until disease progression * Complete Health-related quality of life questionnaire every 2 months for a maximum of 6 months * Participate to the optional translational research: Blood samples fo DPYD genotyping and pharmacokinetic analysis

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

• Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.

• Histological or cytological documentation of adenocarcinoma of the colon or rectum or gastroesophageal cancer (lower oesophagus, gastroesophageal junction and gastric)

• Synchronous or metachronous metastatic colorectal or gastroesophageal cancer

• Presence of at least one measurable lesion according to RECIST v1.1

• No prior therapy for metastatic disease

• known DPD deficiency defined as plasma uracil concentration≥16 ng/ml For plasma uracil concentration \[16-20\[ ng/ml, plasma uracil dosage must be repeated in the 7 days to confirm that plasma uracil concentration ≥16 ng/ml. If the second result is different (i.e; uracil concentration \<16 ng/ml), keep the favourable result, and do not include the patient if only the first plasma uracil concentration≥16 ng/ml.

• Age ≥18 years

• Eastern Cooperative Oncology Group (ECOG) performance status ≤1

• Adequate bone marrow, renal and liver functions as evidenced by the following laboratory requirements within 7 days prior to study treatment initiation:

∙ Absolute neutrophil count (ANC) ≥ 1,500/ mm³ without biologic response modifiers such as granulocyte colony-stimulating factor (G-CSF), within 21 days before the start of study treatment

‣ Platelet count ≥100,000/mm³, without platelet transfusion within 21 days before the start of study treatment

‣ Hemoglobin (Hb) ≥9 g/dL, without blood transfusion or erythropoietin within 21 days before the start of study treatment

‣ Serum creatinine ≤1.5 x upper limit of normal (ULN)

‣ Glomerular filtration rate as assessed by the estimated glomerular filtration rate (eGFR) ≥50 mL/min per 1.73 m² calculated by the Modification of Diet in Renal Disease (MDRD) abbreviated formula

‣ Total bilirubin ≤ 1.5 x ULN

‣ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)

‣ Alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5.0 x ULN for patients with liver involvement for their cancer and/or bone metastases)

‣ International normalized ratio (INR) ≤1.5 or prothrombin time (PT) ≤1.5 x ULN Note: Patients on stable dose (dose has not been changed in at least 28 days) of anticoagulation therapy will be allowed to participate if they have no sign of bleeding or clotting and INR / PT and PTT / aPTT test results are compatible with the acceptable benefit-risk ratio at the investigator's discretion. In such case, limits as noted would not apply

⁃ For women of reproductive potential, negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test obtained within 7 days before the start of study treatment. Women not of reproductive potential are female patients who are postmenopausal or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy)

⁃ For women of childbearing potential and men, agreement to use an adequate contraception for the duration of study participation and up to 7 months following completion of therapy.

⁃ Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

⁃ Affiliation to the Social Security System (or equivalent).

Locations
Other Locations
France
CHU Amiens
NOT_YET_RECRUITING
Amiens
Institut de Cancérologie de l'Ouest
NOT_YET_RECRUITING
Angers
Institut du Cancer d'Avignon
ACTIVE_NOT_RECRUITING
Avignon
CHU Jean Minjoz
ACTIVE_NOT_RECRUITING
Besançon
Centre Hospitalier de Cholet
ACTIVE_NOT_RECRUITING
Cholet
Centre Georges François Leclerc
WITHDRAWN
Dijon
Hôpital Privé Jean Mermoz
ACTIVE_NOT_RECRUITING
Lyon
Institut Régional du Cancer de Montpellier - ICM Val d'Aurelle
ACTIVE_NOT_RECRUITING
Montpellier
Hôpital Cochin
ACTIVE_NOT_RECRUITING
Paris
Hôpital des Diaconesses Croix Saint Simon
ACTIVE_NOT_RECRUITING
Paris
Hôpital Saint Antoine
RECRUITING
Paris
Hôpital Saint Louis
ACTIVE_NOT_RECRUITING
Paris
Hospices Civils de Lyon
NOT_YET_RECRUITING
Pierre-bénite
CHU de Poitiers
ACTIVE_NOT_RECRUITING
Poitiers
CHU de REIMS
ACTIVE_NOT_RECRUITING
Reims
Institut Godinot
RECRUITING
Reims
CHU Saint-Etienne
NOT_YET_RECRUITING
Saint-priest-en-jarez
CH de Saint-Malo
ACTIVE_NOT_RECRUITING
St-malo
Hôpital Nord Franche-Comté / Site du Mittan
ACTIVE_NOT_RECRUITING
Trévenans
Institut de Cancérologie de Lorraine
NOT_YET_RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Emilie BRUMENT
e-brument@unicancer.fr
+33(0)6 68 32 03 59
Time Frame
Start Date: 2025-03-21
Estimated Completion Date: 2028-10-21
Participants
Target number of participants: 73
Treatments
Other: Colorectal adenocarcinoma
Trifluridine/tipiracil in association with oxaliplatin with or without:~* Panitumumab in RAS wild type tumors~* Bevacizumab in RAS wild type of right colon or RAS mutated tumors
Other: Gastroesophageal adenocarcinoma
Trifluridine/tipiracil in association with oxaliplatin with or without:~* Trastuzumab in HER2-positive tumors (3+ IHC or 2+/FISH+)~* Nivolumab if CPS≥5 and HER2-negative tumors
Sponsors
Collaborators: Servier
Leads: UNICANCER

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

We couldn't find any related articles check for more on the main search page.