Gemcitabine/Taxotere/Xeloda (GTX) With Cisplatin in Subjects With Metastatic Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01459614|
Recruitment Status : Active, not recruiting
First Posted : October 25, 2011
Results First Posted : January 23, 2019
Last Update Posted : May 31, 2019
To assess the efficacy of the combination of gemcitabine, taxotere, and xeloda (GTX) with cisplatin in subjects with metastatic pancreatic cancer based on the progression-free survival (PFS) rate at 6 month.
- To assess safety and characterize toxicities of the combination of GTX with cisplatin in subjects with metastatic pancreatic cancer.
- To estimate 3, 6, 9, 12, 15, and 18 month disease control rate (DCR), PFS, and overall survival (OS).
This study is a single arm phase II study to assess the efficacy of GTX with cisplatin in subjects with metastatic pancreatic cancer. Approximately 38 evaluable subjects will be enrolled, 28 in the initial cohort and 10 in the expansion cohort
The study will have a safety run-in phase consisting of 6 subjects. To ensure that the combination is safe, the first six subjects will be treated at DL1 and observed for limiting toxicity for the first 2 cycles before continuation with further accrual. After the safety run-in, the study will be continuously monitored for adverse events.
The primary endpoint will be the PFS rate at 6 month, which is defined as the proportion of subjects alive, free of disease progression at 6 months. The treatment regimen would be considered of insufficient activity for further study in this population if PFS rate at 6 months is 50% or less, and the minimum required level of efficacy that would warrant further study with the proposed regimen is a 75% PFS rate at 6 months. The study design includes interim monitoring for futility using a predictive probability approach. We will stop the study early if given the information at the interim analysis, it is unlikely that the PFS rate at 6 months will be greater than 50% if the study continues to the end.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine Drug: Taxotere Drug: Xeloda Drug: Cisplatin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin in Subjects With Metastatic Pancreatic Cancer|
|Actual Study Start Date :||November 2011|
|Actual Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||November 2019|
Each cycle is 21 days (2 weeks Tx + 1 week off). Xeloda given days 1-14, Gemcitabine, Taxotere, and Cisplatin given days 4 and 11.
For expansion cohort, each cycle is 28 days (2 weeks of Tx + 2 weeks off)
IV at 10mg/m2/min (50 minutes for 500mg/m2) on Days 4 and 11
IV on Days 4 and 11
Other Name: Docetaxel
orally, twice a day Days 1-14
Other Name: Capecitabine
IV Days 4 and 11
- Percentage of Participants Without Disease Progression (Progression-Free Survival) at 6 Months [ Time Frame: 6 months ]Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase from nadir in the sum of the longest diameter of target lesions, or a unequivocal progression in non-target lesions, or the appearance of new lesions
- Safety as Assessed by Number of Participants Experiencing Adverse Events (AEs) as Defined by CTCAE v4.0 [ Time Frame: Up to 18 months ]Number of participants with metastatic pancreatic cancer who received combination of GTX with cisplatin, experiencing AEs as defined by CTCAE v4.0
- Disease Control Rate (DCR) [ Time Frame: Up to 18 months ]Percentage of participants who have achieved partial (PR) or complete response (CR), or stable disease at 3 months, 6 months, 9 months, 12 months, 15 months, and 18 months.
- Progression-free Survival (PFS) [ Time Frame: Up to 60 months ]Time (in months) until disease progression or death, whichever occurs first.
- Overall Survival (OS) [ Time Frame: Up to 60 months ]Time (in months) until death from any cause.
- PFS of an Expansion Cohort Testing an Alternative Schedule [ Time Frame: Up to 60 months ]Time (in months) until disease progression or death, whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459614
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Dung Le, MD||The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|