Trial Evaluating the Efficacy and the Safety of FOLFIRINOX3 Treatment in Patients With Unresectable Locally Advanced or Metastatic Pancreatic Cancer in First Line of Chemotherapy (FOLFIRINOX3 P)

Centre Georges Francois Leclerc

Status and phase

Enrolling

Phase 2

Conditions

Metastatic Pancreatic Cancer

Treatments

Drug: FOLFIRINOX treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT05988814

2023-505889-29-00

Details and patient eligibility

About

Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with locally advanced unresectable or metastatic pancreatic cancer.

Full description

Evaluate the efficacy of treatment FOLFORINOX 3 in first-line therapy for patients with locally advanced unresectable or metastatic pancreatic cancer.

Treatment with FOLFIRINOX3 will be administered with a maximum of 16 courses divided into two 8-course doses. Maintenance treatment (folinic acid/calcium levofolinate + 5-FU) will be administered until progression.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female age > 18 years at time of study entry
Performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG)
Patients with pancreatic adenocarcinoma
Patients with unresectable locally advanced pancreatic cancer or metastatic pancreatic cancer
Patients with no history of chemotherapy (prior adjuvant or neoadjuvant chemotherapy accepted if the time between the end of chemotherapy and recurrence is greater than 12 months) and no history of curative radiotherapy for metastatic or locally advanced disease. Palliative radiotherapy is accepted.
Patient eligible for treatment with FOLFIRINOX (5-FU, Irinotecan, Oxaliplatin and folinic acid) including but not limited to: No active heart disease An ECG with a QT/QTc interval ˂ to 450 ms for men and ˂ to 470 ms for women. No uncontrolled hypertension defined by systolic pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management. A negative pregnancy test if applicable
Tumor evaluation (CT scan) performed within 4 weeks (28 days) prior to inclusion with at least one measurable lesion according to RECIST 1.1 criteria
Patient fit and able to comply with the protocol for the duration of the study, including treatment, visits, scheduled examinations and follow-up.
Biological, hepatic, renal and serological data within the following limits (tests performed within 7 days of inclusion except for serologies performed within 28 days)
Information given and informed consent signed
Patient affiliated to a social security scheme
Men and women must have an effective contraceptive method.

Exclusion criteria

Patient with neuroendocrine carcinoma or acinar cell carcinoma
Other cancer in the 5 years preceding inclusion or concomitant (except cancer in situ of the uterine cervix or cutaneous basal cell carcinoma).
Presence of brain metastasis(es)
Estimated prognosis < 3 months
History of grade 4 toxicity to oxaliplatin, irinotecan or 5FU if history of adjuvant/neoadjuvant chemotherapy
Sequellar toxicity > grade 1 if previous adjuvant/neoadjuvant chemotherapy
Hypersensitivity to any component of FOLFIRINOX® treatment.
Current participation or participation within 30 days prior to inclusion in another therapeutic trial with an investigational compound and/or completion of radiotherapy within 10 days prior to the start of treatment
Evidence of a homozygous or heterozygous DPYD mutation and/or uracilemia >16ng/mL and/or homozygous UGT1A1 genotype.
Pregnancy, breastfeeding
Inability to sign informed consent or to undergo medical monitoring of the trial for geographical, social or psychological reasons including, but not limited to, psychiatric illness compromising comprehension of information or conduct of the study.
Patient under guardianship, curatorship or safeguard of justice.