AdenocarcinomaPhase 1/2NCT03535727
A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer
A Phase 1/2 study testing Nab-paclitaxel, Gemcitabine and Capecitabine in people with Adenocarcinoma and Pancreatic Neoplasms, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Adenocarcinoma, Pancreatic Neoplasms, Neoplasm, Glandular
- What is being tested?
- Nab-paclitaxel, Gemcitabine and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2018to 3 Oct 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231
About this study
Official title: 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.
Read the detailed description
This was a two-part, single-institution, open-label, dose-escalation, phase 1/2 study to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan in patients with metastatic pancreatic cancer.
Part 1 of the study was a Phase 1 3 + 3 dose escalation study designed to evaluate the maximally tolerated dose (MTD) and safety of increasing doses of nab-paclitaxel in combination with gemcitabine, capecitabine, cisplatin, and irinotecan. There were two cohorts of dose escalations. The two cohorts differed based on the treatment cycle length (28 days for Cohort 1 and 21 days for Cohort 2). Dose escalation started with Cohort 1. Enrollment for Cohort 2 dose level 1 began once dose level 2 of Cohort 1 was shown to be safe and did not exceed MTD.
Part 2 was a Phase 2 expansion cohort study for the evaluation of efficacy once the MTD had been determined.
- Conditions
- Adenocarcinoma, Pancreatic Neoplasms, Neoplasm, Glandular, Neoplasms, Neoplasms Pancreatic, Digestive System Neoplasm
- Being tested
- Nab-paclitaxel, Gemcitabine, Capecitabine, Cisplatin, Irinotecan
- Medical subject headings
- Adenocarcinoma, Pancreatic Neoplasms, Neoplasms, Glandular and Epithelial, Neoplasms, Digestive System Neoplasms, Endocrine Gland Neoplasms, Digestive System Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxelDrug
Also called Abraxane
IV over 30 minutes; Days 1 and 15
GemcitabineDrug
Also called Gemzar
IV over 30 minutes; Days 1 and 15
CapecitabineDrug
Also called Xeloda
PO twice daily (BID); Days 1-7, 15-21
CisplatinDrug
Also called Platinol
IV over 60 minutes; Days 1 and 15
IrinotecanDrug
Also called Camptosar
IV over 30 minutes; Days 1 and 15
Nab-paclitaxelDrug
Also called Abraxane
IV over 30 minutes; Days 4 and 11
GemcitabineDrug
Also called Gemzar
IV over 30 minutes; Days 4 and 11
CapecitabineDrug
Also called Xeloda
PO BID; Days 1- 14
CisplatinDrug
Also called Platinol
IV over 60 minutes; Days 4 and 11
IrinotecanDrug
Also called Camptosar
IV over 30 minutes; Days 4 and 11
| Study group | Role | What they receive |
|---|---|---|
| Phase 1, Cohort 1, Dose level 1 | Experimental | Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 40 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Capecitabine; Drug: Cisplatin; Drug: Irinotecan |
| Phase 1, Cohort 1, Dose level 2 | Experimental | Gemcitabine 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel 60 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID: PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Capecitabine; Drug: Cisplatin; Drug: Irinotecan |
| Phase 1, Cohort 1, Dose level 3 | Experimental | Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 80 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan:20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Capecitabine; Drug: Cisplatin; Drug: Irinotecan |
| Phase 1, Cohort 1, Dose level 4 | Experimental | Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:100 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine:500 PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan:20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Capecitabine; Drug: Cisplatin; Drug: Irinotecan |
| Phase 1, Cohort 1, Dose level 5 | Experimental | Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Capecitabine; Drug: Cisplatin; Drug: Irinotecan |
| Phase 1, Cohort 2, Dose level 1 | Experimental | Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:40 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Capecitabine; Drug: Cisplatin; Drug: Irinotecan |
| Phase 1, Cohort 2, Dose level 2 | Experimental | Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:60 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Capecitabine; Drug: Cisplatin; Drug: Irinotecan |
| Phase 1, Cohort 2, Dose level 3 | Experimental | Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:80 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Capecitabine; Drug: Cisplatin; Drug: Irinotecan |
| Phase 2 Dose Expansion (Cohort 1, DL5) | Experimental | Gemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Receives: Drug: Nab-paclitaxel; Drug: Gemcitabine; Drug: Capecitabine; Drug: Cisplatin; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Gemcitabine.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Measured: 28 days
Maximum Tolerated Dose (MTD) of Nab-paclitaxel.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Nab-paclitaxel: 20, 40, 60, 80, 100,125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Measured: 28 days
Maximum Tolerated Dose (MTD) of Capecitabine.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use. Participants received Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle (Cohort 1) or Days 1-14 of a 21 day cycle (Cohort 2)
Measured: 28 days
Maximum Tolerated Dose (MTD) of Cisplatin.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Measured: 28 days
Maximum Tolerated Dose (MTD) of Irinotecan.
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Measured: 28 days
Progression-free Survival (PFS) Using RECIST 1.1 Criteria
PFS is defined as the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
Measured: 27 months
Secondary outcomes (1)
Safety of the Combination of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Patients With Untreated Metastatic PDA.
Number of patients who received the MTD (Cohort 1, Dose Level 5) that experienced a limiting toxicity. Limiting toxicity was defined as a grade 3 or above treatment-related toxicity, with the following exceptions: 1. Grade 3 anemia that resolves to < grade 2 within 7 days; 2. Grade 3 thrombocytopenia without clinically significant bleeding that resolves to < grade 2 within 7 days; 3. Grade 3 or 4 neutropenia that resolves to <grade 2 within 7 days; 4. Grade 3 or 4 leucopenia/lymphopenia; 5. Grade 3 nausea, vomiting, or diarrhea that resolves to <grade 2 within 72 hours; 6. Grade 3 or 4 asymptomatic laboratory values that resolve to < grade 2 within 7 days; 7. Grade 3 dermatologic AEs that are considered mild in severity but only considered grade 3 because of >30% body surface involvement; 8. Grade 3 fatigue lasting less than 72 hours. This study used the descriptions and grading scales found in the revised NCI CTCAE fV 5.0 for adverse event reporting.
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start21 Jun 2018
- Primary completion3 Oct 2022
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dung Le, MD, Principal investigator, Johns Hopkins Medical Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535727
- Sponsor's protocol ID
- J1847
- Other IDs
- IRB00167664
- Status last verified
- Dec 2024
- First submitted
- 11 May 2018
- Last updated
- 31 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Combination in Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03535727
- Acronym / sponsor ID
- J1847
- Conditions
- Adenocarcinoma, Pancreatic Neoplasms, Neoplasm, Glandular, Neoplasms, Neoplasms Pancreatic, Digestive System Neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Posted 8 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a two-part, single-institution, open-label, dose-escalation, phase 1/2 study to evaluate the clinical activity of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan in patients with metastatic pancreatic cancer.
Part 1 of the study was a Phase 1 3 + 3 dose escalation study designed to evaluate the maximally tolerated dose (MTD) and safety of increasing doses of nab-paclitaxel in combination with gemcitabine, capecitabine, cisplatin, and irinotecan. There were two cohorts of dose escalations. The two cohorts differed based on the treatment cycle length (28 days for Cohort 1 and 21 days for Cohort 2). Dose escalation started with Cohort 1. Enrollment for Cohort 2 dose level 1 began once dose level 2 of Cohort 1 was shown to be safe and did not exceed MTD.
Part 2 was a Phase 2 expansion cohort study for the evaluation of efficacy once the MTD had been determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Phase 1, Cohort 1, Dose level 1 | Experimental | Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: Capecitabine, Drug: Cisplatin, Drug: IrinotecanGemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Nab-paclitaxel: 40 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle |
| Phase 1, Cohort 1, Dose level 2 | Experimental | Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: Capecitabine, Drug: Cisplatin, Drug: IrinotecanGemcitabine 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Nab-paclitaxel 60 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Capecitabine: 500 mg BID: PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle Cisplatin: 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle |
| Phase 1, Cohort 1, Dose level 3 | Experimental | Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: Capecitabine, Drug: Cisplatin, Drug: IrinotecanGemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Nab-paclitaxel: 80 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle Cisplatin 20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle Irinotecan:20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle |
| Phase 1, Cohort 1, Dose level 4 | Experimental | Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: Capecitabine, Drug: Cisplatin, Drug: IrinotecanGemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Nab-paclitaxel:100 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Capecitabine:500 PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle Irinotecan:20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle |
| Phase 1, Cohort 1, Dose level 5 | Experimental | Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: Capecitabine, Drug: Cisplatin, Drug: IrinotecanGemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Nab-paclitaxel:125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle |
| Phase 1, Cohort 2, Dose level 1 | Experimental | Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: Capecitabine, Drug: Cisplatin, Drug: IrinotecanGemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle Nab-paclitaxel:40 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle |
| Phase 1, Cohort 2, Dose level 2 | Experimental | Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: Capecitabine, Drug: Cisplatin, Drug: IrinotecanGemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle Nab-paclitaxel:60 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle Capecitabine:500mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle |
| Phase 1, Cohort 2, Dose level 3 | Experimental | Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: Capecitabine, Drug: Cisplatin, Drug: IrinotecanGemcitabine: 500 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle Nab-paclitaxel:80 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle Capecitabine:500mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle Cisplatin:20 mg/m^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle |
| Phase 2 Dose Expansion (Cohort 1, DL5) | Experimental | Drug: Nab-paclitaxel, Drug: Gemcitabine, Drug: Capecitabine, Drug: Cisplatin, Drug: IrinotecanGemcitabine:500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Nab-paclitaxel:125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nab-paclitaxelAlso: AbraxaneIV over 30 minutes; Days 1 and 15 | Drug | Phase 1, Cohort 1, Dose level 1, Phase 1, Cohort 1, Dose level 2, Phase 1, Cohort 1, Dose level 3, Phase 1, Cohort 1, Dose level 4, Phase 1, Cohort 1, Dose level 5, Phase 2 Dose Expansion (Cohort 1, DL5) |
| GemcitabineAlso: GemzarIV over 30 minutes; Days 1 and 15 | Drug | Phase 1, Cohort 1, Dose level 1, Phase 1, Cohort 1, Dose level 2, Phase 1, Cohort 1, Dose level 3, Phase 1, Cohort 1, Dose level 4, Phase 1, Cohort 1, Dose level 5, Phase 2 Dose Expansion (Cohort 1, DL5) |
| CapecitabineAlso: XelodaPO twice daily (BID); Days 1-7, 15-21 | Drug | Phase 1, Cohort 1, Dose level 1, Phase 1, Cohort 1, Dose level 2, Phase 1, Cohort 1, Dose level 3, Phase 1, Cohort 1, Dose level 4, Phase 1, Cohort 1, Dose level 5, Phase 2 Dose Expansion (Cohort 1, DL5) |
| CisplatinAlso: PlatinolIV over 60 minutes; Days 1 and 15 | Drug | Phase 1, Cohort 1, Dose level 1, Phase 1, Cohort 1, Dose level 2, Phase 1, Cohort 1, Dose level 3, Phase 1, Cohort 1, Dose level 4, Phase 1, Cohort 1, Dose level 5, Phase 2 Dose Expansion (Cohort 1, DL5) |
| IrinotecanAlso: CamptosarIV over 30 minutes; Days 1 and 15 | Drug | Phase 1, Cohort 1, Dose level 1, Phase 1, Cohort 1, Dose level 2, Phase 1, Cohort 1, Dose level 3, Phase 1, Cohort 1, Dose level 4, Phase 1, Cohort 1, Dose level 5, Phase 2 Dose Expansion (Cohort 1, DL5) |
| Nab-paclitaxelAlso: AbraxaneIV over 30 minutes; Days 4 and 11 | Drug | Phase 1, Cohort 2, Dose level 1, Phase 1, Cohort 2, Dose level 2, Phase 1, Cohort 2, Dose level 3 |
| GemcitabineAlso: GemzarIV over 30 minutes; Days 4 and 11 | Drug | Phase 1, Cohort 2, Dose level 1, Phase 1, Cohort 2, Dose level 2, Phase 1, Cohort 2, Dose level 3 |
| CapecitabineAlso: XelodaPO BID; Days 1- 14 | Drug | Phase 1, Cohort 2, Dose level 1, Phase 1, Cohort 2, Dose level 2, Phase 1, Cohort 2, Dose level 3 |
| CisplatinAlso: PlatinolIV over 60 minutes; Days 4 and 11 | Drug | Phase 1, Cohort 2, Dose level 1, Phase 1, Cohort 2, Dose level 2, Phase 1, Cohort 2, Dose level 3 |
| IrinotecanAlso: CamptosarIV over 30 minutes; Days 4 and 11 | Drug | Phase 1, Cohort 2, Dose level 1, Phase 1, Cohort 2, Dose level 2, Phase 1, Cohort 2, Dose level 3 |
Primary outcome
Maximum Tolerated Dose (MTD) of Gemcitabine.
Time frame: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Gemcitabine: 500 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Maximum Tolerated Dose (MTD) of Nab-paclitaxel.
Time frame: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Nab-paclitaxel: 20, 40, 60, 80, 100,125 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Maximum Tolerated Dose (MTD) of Capecitabine.
Time frame: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use. Participants received Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle (Cohort 1) or Days 1-14 of a 21 day cycle (Cohort 2)
Maximum Tolerated Dose (MTD) of Cisplatin.
Time frame: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Cisplatin:20 mg/m^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Maximum Tolerated Dose (MTD) of Irinotecan.
Time frame: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m^2. Participants received Irinotecan: 20 mg/m^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle (Cohort 1) or Days 4 and 11 of a 21 day cycle (Cohort 2)
Progression-free Survival (PFS) Using RECIST 1.1 Criteria
Time frame: 27 months
PFS is defined as the number of months from the date of first dose to disease progression (progressive disease [PD] or relapse from complete response [CR] as assessed using RECIST 1.1 criteria) or death due to any cause. Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions. Estimation based on the Kaplan-Meier curve.
1 secondary outcome
Safety of the Combination of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Patients With Untreated Metastatic PDA.
Time frame: 27 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dung Le, MD principal investigator
Johns Hopkins Medical Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nab-paclitaxel, Gemcitabine and Capecitabine in people with Adenocarcinoma and Pancreatic Neoplasms, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Gemcitabine. (time frame: 28 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.