Expired Study
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Baltimore, Maryland 21231


Purpose:

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.


Study summary:

The study is being done in 2 parts. The first part is the dose escalation part 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 will use these defined doses to look at how effective these drugs are against advanced pancreatic cancer.


Criteria:

Inclusion Criteria: 1. Histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma. 2. Have measurable disease. 3. Male or non-pregnant and non-lactating female of age >18 years. 4. ECOG performance status of 0 to 1 . ECOG 0 indicates that the patient is fully active and able to carry on all pre-disease activities without restriction; and, ECOG 1 indicates that the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature 5. Subjects must have adequate organ and marrow function. 6. Must use acceptable form of birth control prior to study and and for the duration of study. 7. Willing and able to comply with study procedures Exclusion Criteria: 1. Patient who have had any prior chemotherapy within 5 years of enrollment. 2. Patient who have had radiotherapy for pancreatic cancer. 3. Age ≥ 76 years 4. Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study. 5. Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study. 6. Patient who has known brain metastases. 7. Patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, taxotere, xeloda, cisplatin, or irinotecan. 8. Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 9. Patient who has serious medical risk factors involving any of the major organ systems. 10. Patient who has known history of infection with HIV, hepatitis B, or hepatitis C. 11. Pregnant or breast feeding. 12. Patient is unwilling or unable to comply with study procedures 13. Patient with clinically significant wound


NCT ID:

NCT02324543


Primary Contact:

Principal Investigator
Dung Le, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21231
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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