Mode
Text Size
Log in / Sign up
Phase 2 Completed N=48 Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search