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Tyrosine Kinase Inhibitor
Combination Chemotherapy for Pancreatic Cancer
Phase 1
Waitlist Available
Led By Dana B Cardin
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cytologically or histologically confirmed pancreatic adenocarcinoma (excluding islet cell or ampullary tumors) that is metastatic or unresectable
Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Must not have
Malabsorption syndrome or other condition that would interfere with intestinal absorption
Human immunodeficiency virus (HIV) positive patients who are on combination antiretroviral therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing gemcitabine, dasatinib, and erlotinib to treat pancreatic cancer. The goal is to find the best dose with the least side effects.
Who is the study for?
This trial is for adults with pancreatic cancer that has spread or can't be surgically removed. They may have had previous chemotherapy, but not with gemcitabine unless it was over 6 months ago. Participants need to have a life expectancy over 3 months, normal kidney function or specific clearance levels, and must use contraception if applicable. They should be able to swallow pills and have certain blood cell counts within specified ranges.
What is being tested?
The trial tests the combination of gemcitabine hydrochloride (chemotherapy) with dasatinib and erlotinib hydrochloride (enzyme blockers) in treating advanced pancreatic cancer. It aims to find the safest doses and observe how well these drugs work together to stop tumor growth by killing cells or preventing them from dividing.
What are the potential side effects?
Potential side effects include reactions related to chemotherapy such as nausea, fatigue, hair loss, low blood counts leading to increased infection risk; enzyme blocker-related issues like rash or diarrhea; organ inflammation; allergic reactions; heart problems due to dasatinib; and liver function changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My pancreatic cancer cannot be removed by surgery and is not an islet cell or ampullary tumor.
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I am fully active and can carry on all pre-disease activities without restriction.
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My kidney function, measured by creatinine levels or clearance, is normal or near normal.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have conditions affecting my body's ability to absorb nutrients.
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I am HIV positive and on combination antiretroviral therapy.
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I am not pregnant and will stop breastfeeding if treated with erlotinib or dasatinib.
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I have cancer that has spread to my brain.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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I have not had major surgery in the last 4 weeks.
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I am allergic to drugs similar to dasatinib, erlotinib, or gemcitabine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Overall survival (OS)
Progression free survival (PFS)
Response duration
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (gemcitabine, dasatinib, erlotinib)Experimental Treatment3 Interventions
Patients receive gemcitabine hydrochloride IV over 30-60 minutes on days 1, 8, and 15, and dasatinib PO QD and erlotinib hydrochloride PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dasatinib
2012
Completed Phase 3
~2320
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5420
Erlotinib Hydrochloride
2010
Completed Phase 2
~2900
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,886 Previous Clinical Trials
41,020,918 Total Patients Enrolled
Dana B CardinPrincipal InvestigatorVanderbilt University/Ingram Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking strong drugs that affect liver enzyme CYP3A4.It's been over 4 weeks since my last radiation dose, and I have measurable cancer outside the treated area.I haven't had chemotherapy or radiotherapy in the last 4-6 weeks and have recovered from any side effects.I am not pregnant and will stop breastfeeding if treated with erlotinib or dasatinib.I have cancer that has spread to my brain.Your white blood cell count is at least 3,000 per microliter.Your blood platelet count is at least 100,000 per microliter.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.You have enough infection-fighting white blood cells in your body.My kidney function, measured by creatinine levels or clearance, is normal or near normal.I do not have conditions affecting my body's ability to absorb nutrients.I do not have any active cancer except for treated skin cancer.I am fully active and can carry on all pre-disease activities without restriction.I am HIV positive and on combination antiretroviral therapy.I don't have serious heart issues like recent heart attacks or abnormal heart rhythms.My pancreatic cancer cannot be removed by surgery and is not an islet cell or ampullary tumor.I've had chemotherapy for advanced disease but not with gemcitabine, or it's been over 6 months since my last dose of gemcitabine, and I've recovered from the side effects.I can swallow pills.I have not had major surgery in the last 4 weeks.You have a tumor that can be measured using specific guidelines for assessing tumor size.Your liver enzymes (AST and ALT) are not too high, unless you have liver metastases, in which case they can be a little higher.I am allergic to drugs similar to dasatinib, erlotinib, or gemcitabine.Your total bilirubin level should be less than 2.5 times the normal limit at the medical center.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (gemcitabine, dasatinib, erlotinib)
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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