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

  • STATUS
    Recruiting
  • End date
    Dec 27, 2021
  • participants needed
    86
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 27 August 2021
measurable lesion
paclitaxel
cancer
measurable disease
pancreatic adenocarcinoma
capecitabine
gemcitabine
irinotecan
primary cancer
adenocarcinoma
metastatic pancreatic cancer
administration intravenous
nab-paclitaxel
metastatic pancreatic adenocarcinoma

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.

Details
Condition Pancreatic Cancer, Gastrointestinal Neoplasm, Endocrine disorder, Endocrine neoplasm, Adenocarcinoma, Cancer, Pancreatic disorder, Carcinoma, GASTROINTESTINAL DISORDER, Neoplasm of unspecified nature of digestive system, Digestive System Disease, Epithelioma, Pancreatic Disorders, Vulvar Dysplasia and Carcinoma, Cancer/Tumors, Gastrointestinal Diseases and Disorders, Ewing's Family Tumors, Advanced Malignancies, Cancer (Pediatric), Islet Ce417ll Cancer, Malignant Adenoma, Neoplasms, Digestive System Neoplasms, digestive system neoplasm, gastrointestinal diseases, gastrointestinal disorders, gastrointestinal disease, pancreatic neoplasm, adenocarcinomas, gastrointestinal tumor, gastrointestinal tract tumor, gastrointestinal tumors, digestive system tumor, digestive disorders, digestive diseases, digestive disorder, digestive disease, endocrinopathy, endocrine disorders, endocrine disease, endocrine diseases, endocrine neoplasia
Treatment Capecitabine, cisplatin, Gemcitabine, Irinotecan, Nab-paclitaxel
Clinical Study IdentifierNCT03535727
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on27 August 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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