Metastatic Pancreatic Adenocarcinoma
Conditions
Keywords
Metastatic Pancreas Ductal Adenocarcinoma
Brief summary
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.
Interventions
DRUGGemcitabine
1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
DRUGPaclitaxel
80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
Sponsors
UNICANCER
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Until death (life expectancy around 12 months) | Time from the date of randomization to the date of death from any cause |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GEMPAX Gemcitabine + Paclitaxel until progression
Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
Paclitaxel: 80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest. | 140 |
| Control Gemcitabine alone until progression
Gemcitabine: 1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest. | 71 |
| Total | 211 |
Baseline characteristics
| Characteristic | Control | Total | GEMPAX |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 105 Participants | 70 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 106 Participants | 70 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment France | 71 participants | 211 participants | 140 participants |
| Sex: Female, Male Female | 28 Participants | 81 Participants | 53 Participants |
| Sex: Female, Male Male | 43 Participants | 130 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 131 / 140 | 68 / 71 |
| other Total, other adverse events | 138 / 140 | 22 / 71 |
| serious Total, serious adverse events | 71 / 140 | 26 / 71 |
Outcome results
Primary
Overall Survival
Time from the date of randomization to the date of death from any cause
Time frame: Until death (life expectancy around 12 months)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| GEMPAX | Overall Survival | 6.4 months |
| Control | Overall Survival | 5.9 months |