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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03535727
Other study ID # J1847
Secondary ID IRB00167664
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date June 21, 2018
Est. completion date October 3, 2022

Study information

Verified date January 2024
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date October 3, 2022
Est. primary completion date October 3, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 76 Years
Eligibility 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.

Study Design


Intervention

Drug:
Nab-paclitaxel
IV over 30 minutes; Days 1 and 15
Gemcitabine
IV over 30 minutes; Days 1 and 15
Capecitabine
PO twice daily (BID); Days 1-7, 15-21
Cisplatin
IV over 60 minutes; Days 1 and 15
Irinotecan
IV over 30 minutes; Days 1 and 15
Nab-paclitaxel
IV over 30 minutes; Days 4 and 11
Gemcitabine
IV over 30 minutes; Days 4 and 11
Capecitabine
PO BID; Days 1- 14
Cisplatin
IV over 60 minutes; Days 4 and 11
Irinotecan
IV over 30 minutes; Days 4 and 11

Locations

Country Name City State
United States Sidney Kimmel Comprehensive Cancer Center Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 28 days
Primary 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) 28 days
Primary 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) 28 days
Primary 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) 28 days
Primary 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) 28 days
Primary 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. 27 months
Secondary 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 27 months
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