Erlotinib + Irinotecan for Advanced Cancer

Palo Alto (17 mi)

Overseen byHenry C Pitot

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?Phase I trial to study the effectiveness of combining erlotinib hydrochloride with irinotecan hydrochloride in treating patients who have advanced solid tumors. Erlotinib hydrochloride may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib hydrochloride and chemotherapy may kill more tumor cells.

Eligibility Criteria

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.

Inclusion Criteria

My eye exam with special dyes showed no abnormalities.

I am not currently on any immunotherapy treatments.

I am not receiving any other chemotherapy treatments.

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

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

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

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

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

I do not have an irregular heartbeat.

I do not have any current infections.

I do not have an active stomach ulcer.

I am not currently undergoing radiotherapy.

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

My eyes are healthy without any cornea problems.

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

My cancer overproduces a protein called EGFR.

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

I do not have heart failure symptoms.

I do not have unstable chest pain.

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

I do not have a seizure disorder.

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

My heart condition does not severely limit my daily activities.

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

I have not taken any EGFR-targeting cancer drugs.

Treatment Details

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.

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.