Overview

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

Status:
Active, not recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UNICANCER
Treatments:
Albumin-Bound Paclitaxel
Gemcitabine
Paclitaxel
Criteria
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