Clinical trialPhase 1 / Phase 2Completed
Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer
Phase 1/2 Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- February 2015
- Expected end
- February 2020
- Enrollment
- 47 participants
- Sites
- 1
- Primary outcomes
- Maximum Tolerated Dose (MTD) of Gemcitabine; Maximum Tolerated Dose (MTD) of Docetaxel; Maximum Tolerated Dose (MTD) of Capecitabine; Maximum Tolerated Dose (MTD) of Cisplatin; Maximum Tolerated Dose (MTD) of Irinotecan
- Sponsor
- Other
- Results posted
- 2020-09-14
- Last update
- 21 July 2023
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Maximum Tolerated Dose (MTD) of Gemcitabine [28 days]. Number, mg/m^2. Phase 1 (n=23): 500.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Maximum Tolerated Dose (MTD) of Docetaxel [28 days]. Number, mg/m^2. Phase 1 (n=23): 20.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Maximum Tolerated Dose (MTD) of Capecitabine [28 days]. Number, mg. Phase 1 (n=23): 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=23): 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=23): 20.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) Rate at 9 Months [9 months]. Number, percentage of participants (95% Confidence Interval). Phase 2 (n=30): 57 (41 to 77).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Rate (RR) Using RECIST 1.1 Criteria [43 months]. Number, percentage of participants (95% Confidence Interval). Phase 2 (n=30): 57 (37 to 75).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Disease Control Rate (DCR) Using RECIST 1.1 Criteria [43 months]. Number, percentage of participants (95% Confidence Interval). Phase 2 (n=30): 87 (69 to 96).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) Using RECIST 1.1 Criteria [5 years]. Median, Months (95% Confidence Interval). Phase 2 (n=30): 8.34 (6.34 to NA) [Upper bound confidence interval was not reached.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [5 years]. Median, Months (95% Confidence Interval). Phase 2 (n=30): 11.02 (8.54 to 21.09).