This study will be looking at whether gemcitabine, taxotere, and xeloda (GTX) in combination with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with metastatic pancreatic cancer.
The study is being done in 2 parts. The first part is the dose escalation (Phase I) part of the study where the dose of irinotecan is increased until the highest safe dose of irinotecan is defined that can be given with gemcitabine, taxotere, xeloda, and cisplatin. After the safe dose of irinotecan in combination with gemcitabine, taxotere, xeloda, and cisplatin is defined, the second part of the study (Phase 2) will use these defined doses to look at how effective these drugs are against advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
IV on days 4 and 11 of a 21 day cycle
IV on days 4 and 11 of a 21 day cycle
Twice a day orally on days 1 through 14 of a 21 day cycle
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Maximum Tolerated Dose (MTD) of Gemcitabine
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
Time frame: 28 days
Maximum Tolerated Dose (MTD) of Docetaxel
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 28 days
Overall Survival (OS) Rate at 9 Months
OS will be measured as the percentage of subjects alive at 9 months. (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (Phase 2 data only)
Time frame: 9 months
Response Rate (RR) Using RECIST 1.1 Criteria
RR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, 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.
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IV on days 4 and 11 of a 21 day cycle
IV on days 4 and 11 of a 21 day cycle
Time frame: 43 months
Disease Control Rate (DCR) Using RECIST 1.1 Criteria
DCR is defined as the percentage of participants achieving a complete response (CR) or partial response (PR) and stable disease (SD) based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) at any time during the study. CR = disappearance of all target lesions, 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.
Time frame: 43 months
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.
Time frame: 5 years
Overall Survival (OS)
OS will be measured (in months) from date of first dose until death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Time frame: 5 years