Gemcitabine and Paclitaxel vs Gemcitabine Alone After FOLFIRINOX Failure in Metastatic Pancreatic Ductal Adenocarcinoma

Study Overview
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Brief Summary
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This study aims to evaluate whether the combination of gemcitabine and paclitaxel allows to improve the overall survival compared to gemcitabine alone, in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC) after FOLFIRINOX failure or intolerance.

Official Title
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A Phase III Randomized Study Evaluating Gemcitabine and Paclitaxel Versus Gemcitabine Alone After FOLFIRINOX Failure or Intolerance in Metastatic Pancreatic Ductal Adenocarcinoma

Conditions
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Metastatic Pancreatic Adenocarcinoma

Intervention / Treatment
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* Drug: Gemcitabine
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Metastatic Pancreatic Ductal Adenocarcinoma with histological or cytological proof Age ≥18 years At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 outside any previously irradiated area Failure of first line FOLFIRINOX (Progressive disease during therapy of within 3 months +/- 15 days) Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 Life expectancy ≥12 weeks Negative serology (HIV, hepatitis B and C) Adequate organs function Proven Post-menopausal status or negative urinary or serum pregnancy test Woman of childbearing potential and male patients must agree to use adequate contraception fo the duration of the trial and up to 6 months after completing treatment Patients affiliated to the social security system Patient must have signed a written informed consent form Exclusion Criteria: Any other primary tumor or secondary malignancy except basal cell carcinoma of skin or in situ carcinoma of the cervix uteri Known cerebral metastasis Uncontrolled severe infections Patients with Kaposi's sarcoma Peripheral neuropathy exceeding grade 2 on Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Previous treatment with taxane and/or gemcitabine (for pancreas cancer only) Patients with known allergy or severe hypersensitivity to any trial drug or drug excipient Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment Patients unable to comply with trial obligations for geographic, social or physical reasons, or who are unable to understand the purpose and procedures of the trial Participation in another clinical trial within 14 days prior to randomization Patients deprived of liberty or under legal protection measures or patients whose willingness to participate in the trial may be unduly influenced

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GEMPAX<br>Gemcitabine + Paclitaxel until progression | Drug: Gemcitabine<br>* 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.<br>* Other names: GEMZAR;Drug: Paclitaxel<br>* 80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.<br>* Other names: TAXOL;|
| Active Comparator: Control<br>Gemcitabine alone until progression | Drug: Gemcitabine<br>* 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.<br>* Other names: GEMZAR;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Time from the date of randomization to the date of death from any cause | Until death (life expectancy around 12 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Pancreas Ductal Adenocarcinoma