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Phase 1/2 Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer
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.
Details
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 47 |
| Start date | 2015-02 |
| Completion | 2020-02 |
Conditions
- Metastatic Pancreatic Adenocarcinoma
Interventions
- Gemcitabine
- Taxotere
- Xeloda
- Cisplatin
- Irinotecan
Primary outcomes
- Maximum Tolerated Dose (MTD) of Gemcitabine — 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. - Maximum Tolerated Dose (MTD) of Docetaxel — 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. - Maximum Tolerated Dose (MTD) of Capecitabine — 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use. - Maximum Tolerated Dose (MTD) of Cisplatin — 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. - Maximum Tolerated Dose (MTD) of Irinotecan — 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2. - Overall Survival (OS) Rate at 9 Months — 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)
Countries
United States