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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adenocarcinoma, Pancreatic Neoplasms, Neoplasm, Glandular, Neoplasms, Neoplasms Pancreatic, Digestive System Neoplasm, Endocrine Gland Neoplasms, Digestive System Disease, Pancreatic Diseases, Endocrine System Diseases

Intervention / Treatment
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* Drug: Nab-paclitaxel
* Drug: Gemcitabine
* Drug: Capecitabine
* Drug: Cisplatin
* Drug: Irinotecan
* Drug: Nab-paclitaxel
* Drug: Gemcitabine
* Drug: Capecitabine
* Drug: Cisplatin
* Drug: Irinotecan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>(28 Days) - Nab-paclitaxel ,Gemcitabine, Capecitabine, Cisplatin and Irinotecan | Drug: Nab-paclitaxel<br>* IV over 30 minutes; Days 1 and 15<br>* Other names: Abraxane;Drug: Gemcitabine<br>* IV over 30 minutes; Days 1 and 15<br>* Other names: Gemzar;Drug: Capecitabine<br>* PO twice daily (BID); Days 1-7, 15-21<br>* Other names: Xeloda;Drug: Cisplatin<br>* IV over 60 minutes; Days 1 and 15<br>* Other names: Platinol;Drug: Irinotecan<br>* IV over 30 minutes; Days 1 and 15<br>* Other names: Camptosar;|
| Experimental: Cohort 2<br>(21 Days) - Nab-paclitaxel ,Gemcitabine, Capecitabine, Cisplatin and Irinotecan | Drug: Nab-paclitaxel<br>* IV over 30 minutes; Days 4 and 11<br>* Other names: Abraxane;Drug: Gemcitabine<br>* IV over 30 minutes; Days 4 and 11<br>* Other names: Gemzar;Drug: Capecitabine<br>* PO BID; Days 1- 14<br>* Other names: Xeloda;Drug: Cisplatin<br>* IV over 60 minutes; Days 4 and 11<br>* Other names: Platinol;Drug: Irinotecan<br>* IV over 30 minutes; Days 4 and 11<br>* Other names: Camptosar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Percentage of participants experiencing toxicities | Percentage of participants by grade of toxicity as defined by CTCAE version 5. | 4 years | 
| Part 2: Progression Free Survival (PFS) | Duration of time (months) from start of treatment to time of first documented progression or death, whichever occurs first. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 2: Response Rate (RR) | Percentage of patients who achieved complete response (CR) or partial response (PR) among all evaluable patients. | 4 years | 
| Part 2: Disease Control Rate (DCR) | Percentage of patients who achieved complete response (CR), partial response (PR), or stable disease (SD) among all evaluable patients. | 4 years | 
| Part 2: Overall survival (OS) | Duration of time (months) from start of treatment to time of death. | 4 years | 
| Part 2: Percentage of participants experiencing toxicities with GAX-CI (gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan, a combinatorial therapy). | Percentage of participants by grade of toxicity as defined by CTCAE version 5. | 4 years |