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.
It has been over 4 weeks since my last immunotherapy or biologic treatment.
I am not currently on any immunotherapy treatments.
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Treatment Details
Interventions
- Erlotinib Hydrochloride (Tyrosine Kinase Inhibitor)
- Irinotecan Hydrochloride (Topoisomerase I inhibitor)
Trial OverviewThe 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.
Participant Groups
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
National Cancer Institute (NCI)Lead Sponsor