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Experimental drug combo targets Hard-to-Treat cancers

NCT ID NCT00045201

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

60 people

The number who actually took part.

Started

Jun 2002

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.