NCT02324543

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Metastatic Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	IV on days 4 and 11 of a 21 day cycle
DRUG	Taxotere	IV on days 4 and 11 of a 21 day cycle
DRUG	Xeloda	Twice a day orally on days 1 through 14 of a 21 day cycle
DRUG	Cisplatin	IV on days 4 and 11 of a 21 day cycle
DRUG	Irinotecan	IV on days 4 and 11 of a 21 day cycle

Timeline

• Start date: 2015-02-01
• Primary completion: 2019-06-01
• Completion: 2020-02-01
• First posted: 2014-12-24
• Last updated: 2023-07-21
• Results posted: 2020-09-14

Locations

1 site across 1 country: United States