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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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
+5 moreSide effects data
From 2018 Phase 2 trial • 29 Patients • NCT0166489748%
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
3%
Pleuritic Pain
3%
Seizure
3%
Tumor Lysis Syndrome
3%
Skin Infection
3%
Thromboembolic Event
3%
Blood and Lymphatic System disorder - other
3%
Espohageal Ulcer
3%
Hematoma
3%
Hyperbilirubinemia
3%
Hypotension
3%
Oral Mucositis
3%
Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Erlotinib Hydrochloride)
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
~2850
Irinotecan Hydrochloride
2010
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,093 Total Patients Enrolled
Henry C PitotPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.It's been over 4 weeks since my last chemotherapy, 6 for certain types, and I've recovered.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.Not applicable.I do not need IV feeding.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.I am not receiving any other chemotherapy treatments.It has been over 4 weeks since my last radiation treatment.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 tumor can be biopsied twice at the same spot.My heart condition does not severely limit my daily activities.I have not had a major injury in the last 3 weeks.I do not have any other serious illnesses that are not under control.I have not taken any EGFR-targeting cancer drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (enzyme inhibitor, chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the reported dangers of Erlotinib Hydrochloride?
"Erlotinib Hydrochloride is still in Phase 1 of clinical trials, meaning that there is limited data to support both its efficacy and safety."
Answered by AI
What does Erlotinib Hydrochloride typically help patients with?
"Erlotinib Hydrochloride, most often used to treat cancer, can also be given to patients that have undergone chemotherapy for their pancreatic or colorectal carcinoma in order to prevent disease progression."
Answered by AI
Are individuals with this condition still being sought for the experiment?
"Unfortunately, the information available on clinicaltrials.gov suggests that this trial is no longer looking for patients. Although the study's last update was on June 28th, 2022, it was first posted on June 13th, 2002. There are, however, 334 other trials that are still recruiting patients."
Answered by AI
What is the efficacy of Erlotinib Hydrochloride in clinical trials?
"There are currently 328 active clinical trials studying Erlotinib Hydrochloride, 63 of which are in Phase 3. While several clinical trials for Erlotinib Hydrochloride are located in Woolloongabba, Queensland, there are a total of 14,392 locations running studies for Erlotinib Hydrochloride."
Answered by AI
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