J1847: A phase I/II study of gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in combination in metastatic pancreatic cancer
Johns Hopkins Kimmel Cancer Center in Baltimore
This study will be looking at whether gemcitabine, nab-paclitaxel, and xeloda (GAX) in combination with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with metastatic pancreatic cancer.
Ages Eligible for Study: 18 Years to 75 Years. Genders Eligible for Study: Both. 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 greater than 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 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 greater than 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, nab-paclitaxel, capecitabine (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
This is a two part, open-label, dose-escalation, phase 1/2 study to evaluate the clinical activity of gemcitabine, nab-paclitaxel, and xeloda (GAX) in combination with cisplatin and irinotecan in patients with metastatic pancreatic cancer. Part 1 of the study is a traditional 3 + 3 dose escalation study designed to evaluate the maximally tolerated dose (MTD), dose limiting toxicities (DLTs), and safety of increasing doses of nab-paclitaxel in combination with gemcitabine, xeloda, cisplatin, and irinotecan. After the safe dose of nab-paclitaxel in combination with gemcitabine, xeloda, cisplatin, and irinotecan is defined, the second part will use these defined doses to look at how effective these drugs are against advanced pancreatic cancer.
03/05/2019 05:03 AM