Pancreatic Cancer > Dasatinib

Combination Chemotherapy for Pancreatic Cancer

Recruiting in Palo Alto (17 mi)

Overseen By Dana Cardin

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of gemcitabine hydrochloride and dasatinib when given together with erlotinib hydrochloride in treating patients with pancreatic cancer that has spread to other places in the body or cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Dasatinib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine hydrochloride and dasatinib together with erlotinib hydrochloride may kill more tumor cells.

Eligibility Criteria

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.

Inclusion Criteria

It's been over 4 weeks since my last radiation dose, and I have measurable cancer outside the treated area.

Your white blood cell count is at least 3,000 per microliter.

Your blood platelet count is at least 100,000 per microliter.

Exclusion Criteria

I am not taking strong drugs that affect liver enzyme CYP3A4.

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.

Participant Groups

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.

Group I: Treatment (gemcitabine, dasatinib, erlotinib) Experimental Treatment 3 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.

Dasatinib is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Sprycel for:

• Chronic myeloid leukemia (CML)
• Acute lymphoblastic leukemia (ALL)

🇪🇺 Approved in European Union as Sprycel for:

• Chronic myeloid leukemia (CML)
• Acute lymphoblastic leukemia (ALL)

🇨🇦 Approved in Canada as Sprycel for:

• Chronic myeloid leukemia (CML)
• Acute lymphoblastic leukemia (ALL)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Vanderbilt University/Ingram Cancer Center Nashville, TN

Who Is Running the Clinical Trial?

National Cancer Institute (NCI) Lead Sponsor

References