Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Adenocarcinoma

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

Gemcitabine

Capecitabine

Docetaxel

Cisplatin

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Topoisomerase I Inhibitors

Enzyme Inhibitors

* Gemcitabine - 400 mg/m\^2
* Taxotere - 20 mg/m\^2
* Xeloda - 500 mg/twice daily (BID)
* Cisplatin - 15 mg/m\^2
* Irinotecan - 20 mg/m\^2

* Gemcitabine - 400 mg/m\^2
* Taxotere - 20 mg/m\^2
* Xeloda - 500 mg/BID
* Cisplatin - 15 mg/m\^2
* Irinotecan - 40 mg/m\^2

* Gemcitabine - 400 mg/m\^2
* Taxotere - 20 mg/m\^2
* Xeloda - 500 mg/BID
* Cisplatin - 15 mg/m\^2
* Irinotecan - 60 mg/m\^2

* Gemcitabine - 500 mg/m\^2
* Taxotere - 20 mg/m\^2
* Xeloda - 500 mg/BID
* Cisplatin - 20 mg/m\^2
* Irinotecan - 20 mg/m\^2

* Gemcitabine - 500 mg/m\^2
* Taxotere - 20 mg/m\^2
* Xeloda - 500 mg/BID
* Cisplatin - 20 mg/m\^2
* Irinotecan - 40 mg/m\^2

Taxotere

Twice a day orally on days 1 through 14 of a 21 day cycle

Xeloda

Dung Le, MD

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 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

Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.

Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use.

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)

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.

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.

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.

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.

Swim Across America Laboratory

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Gemcitabine: 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle

Cisplatin: 15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Dose Level 1 - Phase 1

Gemcitabine: 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Taxotere: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Xeloda: 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle

Cisplatin: 20 mg/m\^2 IV on Days 4 and 11 of a 21 day cycle

Irinotecan: 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Dose Level 1a - Phase 1

Gemcitabine - 500 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle

Cisplatin - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Irinotecan - 40 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Dose Level 1b - Phase 1

Gemcitabine - 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle

Cisplatin -15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Irinotecan - 40 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Dose Level 2 - Phase 1

Gemcitabine - 400 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Taxotere - 20 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Xeloda - 500 mg/BID twice a day orally on days 1-14 of a 21 day cycle

Cisplatin - 15 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Irinotecan - 60 mg/m\^2 IV on days 4 and 11 of a 21 day cycle

Dose Level 3 - Phase 1

Phase 2

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Phase 1

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

This measure was only assessed for Phase 2. Per protocol, the 6 subjects treated at the MTD (DL1a) during dose escalation (Phase 1) were counted toward the total sample size of 30 subjects for the Phase 2 outcome measure.

Spots Global Cancer Trial Database for Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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