Clinical trial NCT02324543: Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer
Official title: Phase 1/2 Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Pancreatic Adenocarcinoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Swim Across America
First posted: 2014-12-24
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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. Eastern Cooperative Oncology Group (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

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) of Gemcitabine
timeFrame: 28 days
measure: Maximum Tolerated Dose (MTD) of Docetaxel
timeFrame: 28 days
measure: Maximum Tolerated Dose (MTD) of Capecitabine
timeFrame: 28 days
measure: Maximum Tolerated Dose (MTD) of Cisplatin
timeFrame: 28 days
measure: Maximum Tolerated Dose (MTD) of Irinotecan
timeFrame: 28 days
measure: Overall Survival (OS) Rate at 9 Months
timeFrame: 9 months
Secondary outcomes:
measure: Response Rate (RR) Using RECIST 1.1 Criteria
timeFrame: 43 months
measure: Disease Control Rate (DCR) Using RECIST 1.1 Criteria
timeFrame: 43 months
measure: Progression-free Survival (PFS) Using RECIST 1.1 Criteria
timeFrame: 5 years
measure: Overall Survival (OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Dung Le, MD
role: PRINCIPAL_INVESTIGATOR
References: