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Anti-metabolites
Chemotherapy Combination for Pancreatic Cancer
Phase 1 & 2
Waitlist Available
Led By Dung Le, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 27 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of 5 drugs to treat metastatic pancreatic cancer.
Who is the study for?
Adults over 18 with untreated metastatic pancreatic adenocarcinoma can join this trial. They should be in good physical condition (ECOG status 0 or 1), have at least one measurable tumor, and agree to use birth control. Those who've had chemotherapy within the last five years, are pregnant or breastfeeding, planning surgery, or have major health risks aren't eligible.
What is being tested?
The study is testing a combination of cancer drugs: gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) on patients with advanced pancreatic cancer to see how effective they are together.
What are the potential side effects?
Possible side effects include nausea and vomiting; hair loss; numbness or tingling in hands/feet; diarrhea; low blood cell counts leading to increased infection risk; fatigue; liver problems; kidney issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 27 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose (MTD) of Capecitabine.
Maximum Tolerated Dose (MTD) of Cisplatin.
Maximum Tolerated Dose (MTD) of Gemcitabine.
+3 moreSecondary study objectives
Safety of the Combination of Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, and Irinotecan (GAX-CI) in Patients With Untreated Metastatic PDA.
Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Cerebral infarction
1%
Dyspnoea
1%
Ischaemic stroke
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
9Treatment groups
Experimental Treatment
Group I: Phase 2 Dose Expansion (Cohort 1, DL5)Experimental Treatment5 Interventions
Gemcitabine:500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:125 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Group II: Phase 1, Cohort 2, Dose level 3Experimental Treatment5 Interventions
Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:80 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Group III: Phase 1, Cohort 2, Dose level 2Experimental Treatment5 Interventions
Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:60 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Group IV: Phase 1, Cohort 2, Dose level 1Experimental Treatment5 Interventions
Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Nab-paclitaxel:40 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Capecitabine:500 mg BID, PO twice daily (BID); Days 1-14 of a 21 day cycle
Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 4 and 11 of a 21 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 4 and 11 of a 21 day cycle
Group V: Phase 1, Cohort 1, Dose level 5Experimental Treatment5 Interventions
Gemcitabine:500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:125 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Group VI: Phase 1, Cohort 1, Dose level 4Experimental Treatment5 Interventions
Gemcitabine:500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel:100 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine:500 PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin:20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan:20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Group VII: Phase 1, Cohort 1, Dose level 3Experimental Treatment5 Interventions
Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 80 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan:20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Group VIII: Phase 1, Cohort 1, Dose level 2Experimental Treatment5 Interventions
Gemcitabine 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel 60 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID: PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Group IX: Phase 1, Cohort 1, Dose level 1Experimental Treatment5 Interventions
Gemcitabine: 500 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Nab-paclitaxel: 40 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Capecitabine: 500 mg BID, PO twice daily (BID); Days 1-7, 15-21 of a 28 day cycle
Cisplatin: 20 mg/m\^2, IV over 60 minutes; Days 1 and 15 of a 28 day cycle
Irinotecan: 20 mg/m\^2, IV over 30 minutes; Days 1 and 15 of a 28 day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab-paclitaxel
2014
Completed Phase 3
~1950
Gemcitabine
2017
Completed Phase 3
~1920
Capecitabine
2013
Completed Phase 3
~3970
Cisplatin
2013
Completed Phase 3
~3120
Irinotecan
2017
Completed Phase 3
~2590
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
33,332 Total Patients Enrolled
Dung Le, MDPrincipal InvestigatorJohns Hopkins Medical Institution
12 Previous Clinical Trials
586 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have cancer that has spread to your brain.You have serious health problems that affect important organs in your body.You have received radiation therapy for pancreatic cancer.You have had allergic reactions in the past to medications that are similar to gemcitabine, nab-paclitaxel, capecitabine, cisplatin, or irinotecan.You have a wound that is causing significant health problems.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1, Cohort 1, Dose level 4
- Group 2: Phase 1, Cohort 2, Dose level 2
- Group 3: Phase 1, Cohort 1, Dose level 1
- Group 4: Phase 1, Cohort 1, Dose level 2
- Group 5: Phase 1, Cohort 1, Dose level 3
- Group 6: Phase 1, Cohort 1, Dose level 5
- Group 7: Phase 1, Cohort 2, Dose level 1
- Group 8: Phase 1, Cohort 2, Dose level 3
- Group 9: Phase 2 Dose Expansion (Cohort 1, DL5)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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