Baltimore, Maryland 21231

  • Endocrine System Diseases

Purpose:

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.


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.


NCT ID:

NCT03535727


Primary Contact:

Principal Investigator
Dung Le, MD
Johns Hopkins Medical Institution

Susan Sartorius-Mergenthaler, RN
Phone: 410-614-3644
Email: Sartosu@jhmi.edu


Backup Contact:

Email: jsantmy1@jhmi.edu
Joann Santmyer, RN
Phone: (410) 583-2970


Location Contact:

Baltimore, Maryland 21231
United States

Susan Sartorius-Mergenthaler, RN
Phone: 410-614-3644
Email: Sartosu@jhmi.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 21, 2021

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