A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Treatments: Albumin-Bound Paclitaxel; Camptothecin; Capecitabine; Cisplatin; Gemcitabine; Irinotecan; Paclitaxel

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.