A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort 1 (28 Days) - Nab-paclitaxel ,Gemcitabine, Capecitabine, Cisplatin and Irinotecan |
Drug: Nab-paclitaxel
IV over 30 minutes; Days 1 and 15
Other Names:
Drug: Gemcitabine
IV over 30 minutes; Days 1 and 15
Other Names:
Drug: Capecitabine
PO twice daily (BID); Days 1-7, 15-21
Other Names:
Drug: Cisplatin
IV over 60 minutes; Days 1 and 15
Other Names:
Drug: Irinotecan
IV over 30 minutes; Days 1 and 15
Other Names:
|
| Experimental: Cohort 2 (21 Days) - Nab-paclitaxel ,Gemcitabine, Capecitabine, Cisplatin and Irinotecan |
Drug: Nab-paclitaxel
IV over 30 minutes; Days 4 and 11
Other Names:
Drug: Gemcitabine
IV over 30 minutes; Days 4 and 11
Other Names:
Drug: Capecitabine
PO BID; Days 1- 14
Other Names:
Drug: Cisplatin
IV over 60 minutes; Days 4 and 11
Other Names:
Drug: Irinotecan
IV over 30 minutes; Days 4 and 11
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Part 1: Percentage of participants experiencing toxicities [4 years]
Percentage of participants by grade of toxicity as defined by CTCAE version 5.
- Part 2: Progression Free Survival (PFS) [4 years]
Duration of time (months) from start of treatment to time of first documented progression or death, whichever occurs first.
Secondary Outcome Measures
- Part 2: Response Rate (RR) [4 years]
Percentage of patients who achieved complete response (CR) or partial response (PR) among all evaluable patients.
- Part 2: Disease Control Rate (DCR) [4 years]
Percentage of patients who achieved complete response (CR), partial response (PR), or stable disease (SD) among all evaluable patients.
- Part 2: Overall survival (OS) [4 years]
Duration of time (months) from start of treatment to time of death.
- Part 2: Percentage of participants experiencing toxicities with GAX-CI (gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan, a combinatorial therapy). [4 years]
Percentage of participants by grade of toxicity as defined by CTCAE version 5.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Have histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
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Patients with the presence of at least one measurable lesion.
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Male or non-pregnant and non-lactating female of age >18 years.
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Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
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Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
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Must use acceptable form of birth control while on study.
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Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
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Patients who will be considered for surgery are ineligible.
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Patient who have had any prior chemotherapy within 5 years of enrollment.
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Patient who have had radiotherapy for pancreatic cancer.
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Age ≥ 76 years
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Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
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Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study.
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Patient who has known brain metastases.
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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.
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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.
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Patient who has serious medical risk factors involving any of the major organ systems.
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Patient who has known history of infection with HIV, hepatitis B, or hepatitis C.
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Pregnant or breast feeding.
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Patient is unwilling or unable to comply with study procedures
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Patient with clinically significant wound.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | United States | 21231 |
Sponsors and Collaborators
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
- Principal Investigator: Dung Le, MD, Johns Hopkins Medical Institution
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- J1847
- IRB00167664