Clinical trialPhase 1 / Phase 2Completed
A Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan in Metastatic Pancreatic Cancer
A Phase I/II Study of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Combination in Metastatic Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 21 June 2018
- Expected end
- 3 October 2022
- Enrollment
- 48 participants
- Sites
- 1
- Primary outcomes
- Maximum Tolerated Dose (MTD) of Gemcitabine.; Maximum Tolerated Dose (MTD) of Nab-paclitaxel.; Maximum Tolerated Dose (MTD) of Capecitabine.; Maximum Tolerated Dose (MTD) of Cisplatin.; Maximum Tolerated Dose (MTD) of Irinotecan.
- Sponsor
- Other
- Results posted
- 2024-01-08
- Last update
- 31 December 2024
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Maximum Tolerated Dose (MTD) of Gemcitabine. [28 days]. Number, mg/m^2. Phase I (n=40): 500.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Maximum Tolerated Dose (MTD) of Nab-paclitaxel. [28 days]. Number, mg/m^2. Phase 1 (n=40): 125.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Maximum Tolerated Dose (MTD) of Capecitabine. [28 days]. Number, mg BID. Phase I (n=40): 500.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Maximum Tolerated Dose (MTD) of Cisplatin. [28 days]. Number, mg/m^2. Phase 1 (n=40): 20.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Maximum Tolerated Dose (MTD) of Irinotecan. [28 days]. Number, mg/m^2. Phase 1 (n=40): 20.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) Using RECIST 1.1 Criteria [27 months]. Median, months (95% Confidence Interval). Phase 1 MTD/ Phase 2 (n=14): 5.92 (5.52 to NA) [Insufficient number of patients with events.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Safety of the Combination of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Patients With Untreated Metastatic PDA. [27 months]. Count Of Participants, Participants. Phase 1 MTD/ Phase 2 (n=14): 3.