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Tyrosine Kinase Inhibitor

Erlotinib + Irinotecan for Advanced Cancer

Phase 1

Waitlist Available

Led By Henry C Pitot

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

No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)

No concurrent immunotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at least 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether combining a drug that blocks tumor growth with chemotherapy will be more effective at killing tumor cells than chemotherapy alone.

Who is the study for?

This trial is for patients with advanced solid tumors that can't be surgically removed and have no curative or life-extending treatments available. Participants must not have heart disease, active infections, recent injuries, or brain metastases. They should not be pregnant/nursing and must agree to use contraception. No prior EGFR-targeting therapy or certain medications are allowed.

What is being tested?

The study tests combining Erlotinib Hydrochloride (which blocks enzymes aiding tumor growth) with Irinotecan Hydrochloride (chemotherapy). The goal is to see if this combination is more effective in killing tumor cells than when these drugs are used separately.

What are the potential side effects?

Potential side effects include reactions related to the immune system's response to the drugs, fatigue, digestive issues like nausea and diarrhea, blood cell count changes increasing infection risk, liver function alterations, and eye problems due to corneal abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My eye exam with special dyes showed no abnormalities.

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I am not currently on any immunotherapy treatments.

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I am not receiving any other chemotherapy treatments.

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I haven't had radiation on more than a quarter of my bone marrow.

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It has been over 3 weeks since my last major surgery.

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My condition cannot be cured by surgery or any known standard treatment.

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I do not have cancer that has spread to my brain.

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I am able to get out of my bed or chair and move around.

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I do not have an irregular heartbeat.

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I do not have any current infections.

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I do not have an active stomach ulcer.

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I am not currently undergoing radiotherapy.

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I haven't had surgery that affects how my body absorbs food or medicine.

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My eyes are healthy without any cornea problems.

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I am not taking any seizure medications like phenytoin or carbamazepine.

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My cancer overproduces a protein called EGFR.

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My genetic test shows I have a UGT1A1 6/6, 6/7, or 7/7 genotype.

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I do not have heart failure symptoms.

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I do not have unstable chest pain.

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I can take medication by mouth or through a tube in my nose.

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I do not have a seizure disorder.

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I am HIV-positive and not on combination antiretroviral therapy.

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My heart condition does not severely limit my daily activities.

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I do not have any other serious illnesses that are not under control.

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I have not taken any EGFR-targeting cancer drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at least 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at least 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at least 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Correlation of EGFR phosphorylation and/or BCRP expression with response to this combination

Dose limiting toxicity of the combination in all cohorts

Effect of erlotinib hydrochloride on the disposition of irinotecan hydrochloride

+3 more

Side effects data

From 2018 Phase 2 trial • 29 Patients • NCT01664897

48%

Pneumonia

45%

Neutropenic Fever

38%

Shortness of breath

34%

Fatigue

34%

Diarrhea

31%

Lung Infection

28%

Nausea

24%

Rash

17%

Edema

17%

Muscle Aches

17%

Watery eyes

14%

Dizziness

10%

Sepsis

10%

Death

10%

Fever

Tumor Lysis Syndrome

Skin Infection

Thromboembolic Event

Pleuritic Pain

Oral Mucositis

Pain

Seizure

Blood and Lymphatic System disorder - other

Espohageal Ulcer

Hematoma

Hyperbilirubinemia

Hypotension

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Erlotinib Hydrochloride)

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 (enzyme inhibitor, chemotherapy)Experimental Treatment2 Interventions

Patients receive oral erlotinib hydrochloride daily on days -6 to -1. Patients then receive irinotecan hydrochloride IV over 90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Erlotinib Hydrochloride

2010

Completed Phase 2

~2900

Irinotecan Hydrochloride

2010

Completed Phase 3

~2050