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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of Capecitabine.
Maximum Tolerated Dose (MTD) of Cisplatin.
Maximum Tolerated Dose (MTD) of Gemcitabine.
+3 moreSecondary outcome measures
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%
Ischaemic stroke
1%
Dyspnoea
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)
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
Irinotecan
2017
Completed Phase 4
~2680
Capecitabine
2013
Completed Phase 3
~3420
Cisplatin
2013
Completed Phase 3
~1940
Nab-paclitaxel
2014
Completed Phase 3
~2030
Gemcitabine
2017
Completed Phase 3
~2070
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
557 Previous Clinical Trials
32,852 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 2
- Group 2: Phase 1, Cohort 2, Dose level 1
- Group 3: Phase 1, Cohort 1, Dose level 5
- Group 4: Phase 1, Cohort 2, Dose level 2
- Group 5: Phase 1, Cohort 1, Dose level 1
- Group 6: Phase 2 Dose Expansion (Cohort 1, DL5)
- Group 7: Phase 1, Cohort 1, Dose level 4
- Group 8: Phase 1, Cohort 1, Dose level 3
- Group 9: Phase 1, Cohort 2, Dose level 3
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can I qualify to be a part of this clinical research?
"This study requires that potential participants are between 18 and 76 years old, have cancer, and meet one or more of the following conditions: having at least one measurable lesion, being in good physical condition as determined by the ECOG performance status (0 or 1), using birth control while on the medication, and being a male or non-pregnant/non-lactating female over 18 years old."
Answered by AI
What are researchers hoping to discover through this clinical trial?
"The primary objective of this medical trial, which will be conducted over the course of approximately 4 years, is to assess Progression Free Survival (PFS). Additionally, researchers will also measure secondary outcomes including toxicity levels among participants receiving GAX-CI therapy, overall survival rates, and response rates."
Answered by AI
Is Gemcitabine a new medication?
"Gemcitabine is being studied in 2032 active clinical trials, with 604 of those studies classified as Phase 3. Many research centres are situated in Guangzhou, Guangdong; however, there are 95435 total locations conducting Gemcitabine trials worldwide."
Answered by AI
How many individuals are allowed to enroll in this research project?
"That is right, the public information available on clinicaltrials.gov suggests that this study is actively recruiting patients. The listing was created on June 21st, 2018 and updated as recently as March 15th, 2022. This particular trial requires 86 individuals at 2 separate locations."
Answered by AI
Are we recruiting participants who are middle-aged for this research?
"This specific trial is for individuals aged 18 to 76. 514 studies are available for people younger than this age bracket, while 5552 studies focus on patients above the age of 65."
Answered by AI
Are patients being actively recruited for this research project?
"This is an ongoing clinical trial, as reflected by the postings on clinicaltrials.gov. Candidates are actively being sought for the trial which was first posted on 6/21/2018 and last edited on 3/15/2022."
Answered by AI
What are the most popular conditions that Gemcitabine has been known to alleviate?
"Gemcitabine is a medication that is mostly used to treat patients with locally advanced non-small cell lung cancer, however it can also be effective for those suffering from metastatic bladder cancer, urinary bladder, and advanced testicular cancer."
Answered by AI
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