Neoplasms Clinical Trial
Official title:
A Phase I/II Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Combination in Metastatic Pancreatic Cancer
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
United States,
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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