CompletedPhase 2

Nab-Paclitaxel + Cisplatin + Gemcitabine in Untreated Metastatic Pancreatic Adenocarcinoma

United States42 participantsStarted 2019-07-15

Plain-language summary

This is a phase II open-label study evaluating the efficacy and safety of nab-paclitaxel cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma.

Who can participate

Age range18 Years – 105 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years of age; male or female
✓. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
✓. Capable of providing informed consent and complying with trial procedures.
✓. Karnofsky Performance Status (KPS) of ≥ 70%.
✓. Life expectancy ≥ 12 weeks.
✓. Measurable tumor lesions according to RECIST 1.1 criteria.
✓. \< Grade 2 pre-existing peripheral neuropathy per NCI CTCAE, Version 5.0
✓. Patient has acceptable coagulation status as indicated by an international normalized ratio (INR) ≤1.5 x ULN. Patients on anticoagulation can be included at the discretion of the investigator.

Exclusion criteria

✕. Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the neoadjuvant and/or adjuvant setting with gemcitabine and/or Fluorouracil (5-FU) based therapies or gemcitabine and/or 5FU administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
✕. Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
✕. Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
✕. Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
✕. History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥5 years.
✕. Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
✕. History of HIV infection.
✕. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.

What they're measuring

12- Month Overall Survival (OS)

Timeframe: 12 months

Trial details

NCT IDNCT03915444

SponsorHonorHealth Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-13

Results submitted2024-01-03

View on ClinicalTrials.gov More Pancreatic Ductal Adenocarcinoma trials