Phase 2
Completed N=48
A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer
Adenocarcinoma · Pancreatic Cancer · Neoplasm, Glandular · Neoplasms
Source: ClinicalTrials.gov NCT03535727 ↗
Enrolled (actual)
48
Serious AEs
45.8%
Results posted
Jan 2024
Primary outcomePrimary: Maximum Tolerated Dose (MTD) of Gemcitabine. — 500 mg/m^2
Summary
The purpose of this study is to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with metastatic pancreatic cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Gemcitabine. |
500 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of Nab-paclitaxel. |
125 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of Capecitabine. |
500 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of Cisplatin. |
20 | — |
| PRIMARY Maximum Tolerated Dose (MTD) of Irinotecan. |
20 | — |
| PRIMARY Progression-free Survival (PFS) Using RECIST 1.1 Criteria |
5.92 | — |
| SECONDARY Safety of the Combination of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Patients With Untreated Metastatic PDA. |
3 | — |
Eligibility Criteria
Inclusion Criteria
- Have histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
- Patients with the presence of at least one measurable lesion.
- Male or non-pregnant and non-lactating female of age >18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
- Must use acceptable form of birth control while on study.
- Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria
- Patients who will be considered for surgery are ineligible.
- Patient who have had any prior chemotherapy within 5 years of enrollment.
- Patient who have had radiotherapy for pancreatic cancer.
- Age ≥ 76 years
- Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
- Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study.
- Patient who has known brain metastases.
- Patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, capecitabine, cisplatin, or irinotecan.
- Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patient who has serious medical risk factors involving any of the major organ systems.
- Patient who has known history of infection with HIV, hepatitis B, or hepatitis C.
- Pregnant or breast feeding.
- Patient is unwilling or unable to comply with study procedures
- Patient with clinically significant wound.
Data sourced from ClinicalTrials.gov (NCT03535727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.