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



Status:Recruiting
Conditions:Cancer, Cancer, Cancer, Cancer, Endocrine, Gastrointestinal, Gastrointestinal, Digestive Disease
Therapuetic Areas:Endocrinology, Gastroenterology, Oncology
Healthy:No
Age Range:18 - 76
Updated:11/10/2018
Start Date:June 6, 2018
End Date:June 2021
Contact:Susan Sartorius-Mergenthaler, RN
Email:Sartosu@jhmi.edu
Phone:410-614-3644

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A Phase I/II Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Combination in Metastatic Pancreatic Cancer

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.


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.
We found this trial at
1
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Baltimore, Maryland 21231
Phone: 410-614-3644
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