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Adult Solid NeoplasmPhase 1NCT00045201

Erlotinib Hydrochloride and Irinotecan Hydrochloride in Treating Patients With Advanced Solid Tumors

A Phase 1 study testing Erlotinib Hydrochloride and Irinotecan Hydrochloride in people with Adult Solid Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adult Solid Neoplasm
What is being tested?
Erlotinib Hydrochloride and Irinotecan Hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
13 Jun 2002to 13 Aug 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 50Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase I Trial of OSI-774 and CPT-11 in Patients With Advanced Solid Tumors

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.

Read the detailed description

OBJECTIVES:

  1. Determine the maximum tolerated dose (MTD) of erlotinib (erlotinib hydrochloride) and irinotecan (irinotecan hydrochloride), in relation to presence or absence of UGT1A1*28 polymorphism, in patients with advanced solid tumors that overexpress epidermal growth factor receptor.

II. Determine the dose-limiting toxicity of these regimens in these patients. III. Determine whether erlotinib alters the disposition of irinotecan using a previously described limited sampling model.

IV. Determine factors that influence the disposition of these drugs, including genetic variation in UGT1A1 and BCRP, in patients treated with these regimens.

  1. Determine factors that influence the disposition of these drugs, in terms of tumor BCRP-expression, in tumor samples from patients treated with these drugs at the MTD.

VI. Evaluate the effect of this regimen on epidermal growth factor receptor phosphorylation in these patients.

VII. Assess, preliminarily, any antitumor activity in patients treated with these regimens.

VIII. Correlate, preliminarily, EGFR phosphorylation and/or BCRP -expression with response in tumor samples from these patients.

OUTLINE: This is a dose-escalation study. Patients are stratified according to UGTA1A genotype (all patients regardless of genotype [closed to accrual as of 9/15/04] vs UGT1A1 6/6 genotype vs UGTA1A 6/7 or 7/7 genotype).

Patients receive oral erlotinib hydrochloride daily on days -6 to -1. Patients then receive irinotecan hydrochloride intravenously (IV) over 90 minutes on day 1 and oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients per stratum receive escalating doses of erlotinib hydrochloride and irinotecan hydrochloride until the MTD is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD.

Patients are followed for 3 months.

Being tested
Erlotinib Hydrochloride, Irinotecan Hydrochloride

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erlotinib HydrochlorideDrug

    Also called CP 358, CP-358, Cp-358,774, CP358

    Given orally

  • Irinotecan HydrochlorideDrug

    Also called Campto, Camptosar, Camptothecin 11, Camptothecin-11

    Given IV

Study groups in NCT00045201
Study groupRoleWhat they receive
Treatment (enzyme inhibitor, chemotherapy)ExperimentalPatients 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.
Receives: Drug: Erlotinib Hydrochloride; Drug: Irinotecan Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD of erlotinib hydrochloride and irinotecan hydrochloride in patients with advanced solid tumors that overexpress epidermal growth factor receptor

    Defined as the highest safely tolerated dose where at most one patient experiences DLT with the next higher dose having at least 2 patients who experience DLT. Three patients will be entered at a given dose level and observed for at least 4 weeks to assess toxicity. MTD will be determined independently for each cohort.

    Measured: At least 4 weeks

  2. Dose limiting toxicity of the combination in all cohorts

    Defined as an adverse event attributed (definitely, probably, or possibly) to the study treatment. Graded using the National Cancer Institute Common Toxicity Criteria (CTC) version 2.0. Defined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) versioun 4.0.

    Measured: At least 4 weeks

  3. Effect of erlotinib hydrochloride on the disposition of irinotecan hydrochloride

    Analysis performed using high performance liquid chromatography assays. Serial blood samples will be obtained during Cycle 1 only to determine the pharmacokinetics of irinotecan hydrochloride and erlotinib hydrochloride.

    Measured: Weekly during course 1

  4. Effect of erlotinib on EGFR phosphorylation at MTD

    Measured: Weekly during course 1

  5. Genetic variation in UGT1A1 and BCRP

    Detected using allele-specific restriction fragment length polymorphism (RFLP) assays and GeneScan assays. The overall incidence of UTG1A1 polymorphism will be estimated and summarized.

    Measured: Weekly during course 1

  6. Tumor BCRP expression in patients treated at the MTD

    Measured: Weekly during course 1

  7. Evidence of anti tumor activity

    Evaluated using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

    Measured: Every 3 weeks

  8. Correlation of EGFR phosphorylation and/or BCRP expression with response to this combination

    Evaluated using modified RECIST criteria.

    Measured: Every 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study start13 Jun 2002
  3. Primary completion13 Sep 2013
  4. Study completion13 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00045201
Sponsor's protocol ID
NCI-2009-00015
Other IDs
NCI-2009-00015, CDR0000256910, 594-02 01, NCI-5351, MAYO-MC0112, MC0112, 5351, P30CA015083
Status last verified
Aug 2026
First submitted
6 Sep 2002
Last updated
17 Aug 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Erlotinib Hydrochloride and Irinotecan Hydrochloride in people with Adult Solid Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 50 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD of erlotinib hydrochloride and irinotecan hydrochloride in patients with advanced solid tumors that overexpress epidermal growth factor receptor (time frame: At least 4 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00045201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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