Experimental drug combo targets Hard-to-Treat cancers
NCT ID NCT00045201
First seen Jun 26, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This early-phase trial is testing whether combining two drugs—erlotinib and irinotecan—can safely treat advanced solid tumors that have not responded to standard care. Erlotinib blocks signals that help cancer cells grow, while irinotecan is a chemotherapy drug that stops cancer cells from dividing. The study involves 60 participants and aims to find the best dose and check for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- erlotinib hydrochloride and irinotecan hydrochloride
- What this could lead to
- If this combination proves safe and effective, it could offer a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 60 participants, focused on finding the right dose and checking safety. It is not designed to prove the treatment works, and side effects from the drug combination could be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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60 people
The number who actually took part.
- Started
-
Jun 2002
- Expected to finish
-
Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed malignancy that overexpresses epidermal growth factor receptor (EGFR) * Unresectable disease for which there is no known standard therapy that ispotentially curative or definitely capable of extending life expectancy * UGT1A1 genotype 6/6, 6/7, or 7/7 * Willing to provide biologic specimens * Lesions amenable for 2 biopsies from the same tumor site (only patients receiving MTD in groups 2 and 3) * No known brain metastases * Performance status - ECOG 0-2 * At least 12 weeks * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST ≤ 2.5 times ULN (5 times ULN if liver metastases present) * Creatinine no greater than 1.5 times ULN * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No New York Heart Association class III or IV heart disease * No gastrointestinal tract disease resulting in an inability to take oral or nasogastric medication * No requirement for IV alimentation * No active peptic ulcer disease * No abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) * No congenital abnormality (e.g., Fuch's dystrophy) * No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) * No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) * No other uncontrolled concurrent illness * No ongoing or active infection * No significant traumatic injury within the past 21 days * No seizure disorder * No psychiatric illness or social situation that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No concurrent grapefruit or grapefruit juice * No smoking during study * More than 4 weeks since prior immunotherapy or biologic therapy * No concurrent immunotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No other concurrent chemotherapy * Not specified * More than 4 weeks since prior radiotherapy * No prior radiotherapy to more than 25% of bone marrow * No concurrent radiotherapy * More than 3 weeks since prior major surgery * No prior surgical procedures affecting absorption * No prior EGFR-targeting therapy (e.g., gefitinib or EKB-569) * No other concurrent investigational therapy * No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin, phenobarbital, carbamazepine, or valproic acid) * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent enrollment on another study involving pharmacological agents for symptom control or therapeutic intent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Oral drug RVU120 put to the test against advanced solid tumors