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Compares treatment options for Metastatic Pancreatic Cancer
Official title Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients
ClinicalTrials.gov ID: NCT05065801
What this study is testing
What is GEMBRAX/FOLFIRINOX Arm A?
GEMBRAX/FOLFIRINOX Arm A is an investigational medicine, being studied as a potential treatment for metastatic pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to evaluate the efficacy of sequential treatment (Gabrinox) comprising Gembrax regimen (Gemcitabine -Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) compared to folfirinox alone in patients treated in first metastatic line pancreatic cancer
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female aged 18 to 75 on the date the consent is signed.
- Histologically or cytologically proven metastatic pancreatic adenocarcinoma. The definitive diagnosis of pancreatic adenocarcinoma metastases will be...
- One or more metastatic lesion (s) measurable (Recist 1.1) by Thoraco-Abdomino-Pelvic scanner (or hepatic MRI and Thoraco-Abdomino-Pelvic scanner not...
- Previous treatment (including radiochemotherapy) for the non-metastatic disease authorized if a delay ≥ 6 months between the last treatment and the...
- WHO performance status ≤ 1
You likely can't join if
- Known brain metastasis.
- Previous treatment with radiotherapy, surgery, chemotherapy or experimental therapy for the treatment of metastatic disease.
- Major surgery, other than diagnostic surgery (that is, surgery done to obtain a diagnostic biopsy without organ harvesting), within 4 weeks of day 1...
- Known Gilbert's syndrome or homozygous for know UGT1A1 \ 28
- Other concomitant cancer or history of cancer, except cervical cancer in situ treated, skin basal or squamous cell carcinoma, superficial bladder...
- Patients with high cardiovascular risk, including, but not limited to, coronary stent or myocardial infarction within the past 6 months.
See the full eligibility criteria
- Male or female aged 18 to 75 on the date the consent is signed.
- Histologically or cytologically proven metastatic pancreatic adenocarcinoma. The definitive diagnosis of pancreatic adenocarcinoma metastases will be made by integrating the histopathological data in the context of the...
- One or more metastatic lesion (s) measurable (Recist 1.1) by Thoraco-Abdomino-Pelvic scanner (or hepatic MRI and Thoraco-Abdomino-Pelvic scanner not injected, if the patient is allergic to the product of contrast).
- Previous treatment (including radiochemotherapy) for the non-metastatic disease authorized if a delay ≥ 6 months between the last treatment and the recurrence is respected.
- WHO performance status ≤ 1
- Uracilemia \<16 ng / ml
- Acceptable hematological assessment at inclusion (obtained within 14 days before the start of treatment) defined by: Neutrophils ≥ 2 × 109 / L; Platelets ≥ 100,000 / mm3 (100 × 109 / L); Hemoglobin ≥ 9 g / dl.
- Acceptable renal and hepatic function at inclusion (obtained within 14 days before the start of treatment) defined by: AST and ALT ≤ 2.5 x upper limit of the norm (ULN), unless liver metastases are present in this case...
- Calcemia AND magnesemia AND kalaemia ≥ LLN and ≤ 1.2 x ULN
- If the patient is sexually active, he must agree to use contraception deemed adequate and appropriate by the investigator throughout the period of administration of the study drug and up to 6 months after...
- Signature of consent before any procedure specific to the study.
- Affiliated with the French national social security.
- Known brain metastasis.
- Previous treatment with radiotherapy, surgery, chemotherapy or experimental therapy for the treatment of metastatic disease.
- Major surgery, other than diagnostic surgery (that is, surgery done to obtain a diagnostic biopsy without organ harvesting), within 4 weeks of day 1 of study treatment.
- Known Gilbert's syndrome or homozygous for know UGT1A1 \ 28
- Other concomitant cancer or history of cancer, except cervical cancer in situ treated, skin basal or squamous cell carcinoma, superficial bladder tumor (Ta, Tis, and T1) or a tumor with a good prognosis treated...
- Patients with high cardiovascular risk, including, but not limited to, coronary stent or myocardial infarction within the past 6 months.
- Peripheral sensory neuropathy ≥ grade 2 at the time of inclusion.
- ECG with a QTc interval greater than 450 ms for men and greater than 470 ms for women
- Any other concomitant and unbalanced disease or serious disturbance that may interfere with the patient's participation in the study and his safety during the study (eg severe hepatic, renal, pulmonary, metabolic, or...
- Allergy or intolerance to any study drug (gemcitabine, nab-paclitaxel, oxaliplatin, irinotecan, 5-FU) or any excipient (e.g., fructose) as described in the sections " contraindication or special warnings and...
- Pregnant or breastfeeding women. Women of childbearing potential must have a negative pregnancy test (serum β-hCG) within 72 hours prior to inclusion.
- Patients on vitamin K antagonists (e.g., Coumadin) (modifications to treatment may be required prior to inclusion).
- Treatment with brivudine within 4 weeks before or after treatment with 5-fluorouracil (due to a potentially fatal interaction).
- Active and uncontrolled bacterial, viral, or fungal infections requiring systemic treatment.
- Active HIV infection, known hepatitis B or C infection.
- History of peripheral arterial disease (e.g., claudication, Buerger's disease), chronic inflammatory bowel disease or rectal disease, pulmonary fibrosis or interstitial pneumonia.
- Administration of a live attenuated vaccine within 10 days before inclusion and up to 6 months post-treatment.
- Patient refusal or inability to comply with study procedures.
- Inability to undergo follow-up for geographical, social, or psychological reasons.
- Participation in another clinical trial involving an investigational product within the 30 days prior to inclusion.
- Legal incapacity (patient under guardianship or guardianship).
The study team makes the final eligibility decision.
Where it's taking place
- Grenoble, Auvergne-Rhône-Alpes, France
- Saint-Etienne, Auvergne-Rhône-Alpes, France
- Reims, Grand Est, France
- Montpellier, Herault, France
- Montpellier, Hérault, France
- Perpignan, Pyrénées-Orientales, France
- Dijon, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grenoble, Auvergne-Rhône-Alpes, France; Saint-Etienne, Auvergne-Rhône-Alpes, France; Reims, Grand Est, France; Montpellier, Herault, France; Montpellier, Hérault, France; Perpignan, Pyrénées-Orientales, France and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.