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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

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 more

Awards & 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