Triple chemo cocktail shows promise against tough pancreatic cancer
NCT ID NCT03915444
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tested a combination of three chemotherapy drugs (nab-paclitaxel, cisplatin, and gemcitabine) in 42 people with metastatic pancreatic cancer that had not been treated before. The main goal was to see how many patients were alive after 12 months. The study also tracked side effects and tumor shrinkage. Results suggest this combo may improve survival, but larger studies are needed to confirm.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nab-paclitaxel, cisplatin, and gemcitabine (three chemotherapy drugs given together)
- What this could lead to
- If successful, this combination could offer a new treatment option to help people with metastatic pancreatic cancer live longer.
- What could go wrong
- This is a small, early-phase trial (42 people) without a comparison group. The results may not apply to everyone, and the drugs can cause serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
42 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Jan 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 105 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years of age; male or female 2. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. 3. Capable of providing informed consent and complying with trial procedures. 4. Karnofsky Performance Status (KPS) of ≥ 70%. 5. Life expectancy ≥ 12 weeks. 6. Measurable tumor lesions according to RECIST 1.1 criteria. 7. \< Grade 2 pre-existing peripheral neuropathy per NCI CTCAE, Version 5.0 8. 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. 9. Patients must have normal organ and marrow function as defined below: * Absolute neutrophil count ≥1,500/mm3 * Platelet concentration ≥100,000/mm3 with no platelet transfusions within 7 days prior to laboratory sample * Hemoglobin \> 9.0g/dL * Hematocrit level \> 27% * Total bilirubin within 1.25 times institutional upper limit of normal (ULN) * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 10 × institutional ULN * Serum creatinine \<1.5 mg/dl 10. Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy \[the surgical removal of the uterus\] or bilateral oophorectomy \[the surgical removal of both ovaries\] or (2) has not been naturally postmenopausal for at least 24 consecutive months \[i.e., has had menses at any time during the preceding 24 consecutive months\]) must: 1. Either commit to true abstinence\* from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP therapy (including dose interruptions), and while on study medication or for a longer period if required by local regulations following the last dose of IP; and 2. Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence\* from heterosexual contact. 11. Male subjects must practice true abstinence\* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following discontinuation from study treatment, even if he has undergone a successful vasectomy. Exclusion Criteria: 1. 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. 2. Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment. 3. Exposure to any investigational agent within 4 weeks prior to initiation of study treatment. 4. Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit). 5. 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. 6. Current, serious, clinically significant cardiac arrhythmias as determined by the investigator. 7. History of HIV infection. 8. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals. 9. Major surgery within 4 weeks prior to initiation of study treatment. 10. Any condition in the opinion of the principal investigator that might interfere with the patient's participation in the study or in the evaluation of the study results. 11. Any condition in the opinion of the principal investigator that is unstable and could jeopardize the patient's participation in the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
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Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
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University of Miami
Miami, Florida, 33136, United States
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