Completed

A Phase I Study of Single Agent OSI-774 (Tarceva) (NSC# 718781, IND# 63383) Followed by OSI-774 With Temozolomide for Patients With Selected Recurrent/Refractory Solid Tumors, Including Brain Tumors

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What is being tested

erlotinib hydrochloride

+ temozolomide
+ pharmacological study
Drug
Other
Who is being recruted

Astrocytoma
+30

+ Brain Diseases
+ Brain Neoplasms
Until 21 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2004Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of erlotinib in children with recurrent or refractory solid tumors. II. Determine the dose-limiting toxic effects of this drug alone and with temozolomide in these patients. III. Determine the tolerability of this regimen in these patients. IV. Determine the pharmacokinetics of this regimen in these patients. SECONDARY OBJECTIVES: I. Determine, preliminarily, the antitumor activity of this regimen in these patients. OUTLINE: This is a 2-part, multicenter, dose-escalation study of erlotinib. Patients are stratified according to pretreatment (heavily pretreated \[received more than 2 prior multiagent myelosuppressive chemotherapy regimens OR received prior craniospinal or pelvic radiotherapy or bone marrow transplantation OR has bone marrow involvement\] vs less heavily pretreated).Part 1: Patients receive oral erlotinib once daily on days 1-28. Beginning with course 2, patients also receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 23 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib during course 1 only until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Part 2: Patients receive erlotinib (at the MTD) and temozolomide as in part 1. PROJECTED ACCRUAL: A total of 9-45 patients (9-24 for part 1 and up to 21 for part 2) will be accrued for this study.

Official TitleA Phase I Study of Single Agent OSI-774 (Tarceva) (NSC# 718781, IND# 63383) Followed by OSI-774 With Temozolomide for Patients With Selected Recurrent/Refractory Solid Tumors, Including Brain Tumors 
NCT00089934NCT00077454
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
95 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Until 21 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Astrocytoma
Brain Diseases
Brain Neoplasms
Central Nervous System Diseases
Ependymoma
Glioma
Medulloblastoma
Myosarcoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Muscle Tissue
Neoplasms, Nerve Tissue
Nervous System Diseases
Nervous System Neoplasms
Neuroblastoma
Pathologic Processes
Recurrence
Rhabdomyosarcoma
Sarcoma
Osteosarcoma
Central Nervous System Neoplasms
Neuroectodermal Tumors
Neoplasms, Connective and Soft Tissue
Neoplasms, Bone Tissue
Rhabdomyosarcoma, Embryonal
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Disease Attributes
Criteria

Inclusion Criteria: * One of the following histologically confirmed solid tumors: * Brain tumors * Osteogenic sarcoma * Rhabdomyosarcoma * Soft tissue sarcoma (excluding Ewing's sarcoma) * Neuroblastoma * Germ cell tumors * Recurrent or refractory disease * No known curative therapy exists * Performance status - Karnofsky 50-100% (for patients age 11 to 21) * Performance status - Lansky 50-100% (for patients age 10 and under) * At least 8 weeks * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 (transfusion independent\*) * Hemoglobin \> 8.0 g/dL (transfusion allowed) * Bilirubin \< 1.5 times upper limit of normal (ULN) * ALT \< 2.5 times ULN * Albumin ≥ 2 g/dL * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min * Creatinine based on age as follows: * ≤ 0.8 mg/dL for patients age 5 and under * ≤ 1.0 mg/dL for patients 6 to 10 * ≤ 1.2 mg/dL for patients 11 to 15 * ≤ 1.5 mg/dL for patients age 15 to 21 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to swallow tablets (for patients in part 2 only) * No uncontrolled infection * Recovered from all prior immunotherapy * At least 7 days since prior biologic therapy * At least 3 months since prior stem cell transplantation and no evidence of active graft-versus-host disease * More than 1 week since prior growth factors * No concurrent prophylactic growth factor therapy * No concurrent immunotherapy * No concurrent biologic therapy * More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered * No other concurrent chemotherapy * No concurrent systemic corticosteroids except for treatment of increased intracranial pressure or symptomatic tumor edema in patients with CNS tumors * No concurrent steroids as an antiemetic * Concurrent dexamethasone for patients with CNS tumors allowed provided patient has been on a stable or decreasing dose for at least 1 week before study entry * Recovered from all prior radiotherapy * At least 2 weeks since prior local palliative radiotherapy (small port) * At least 6 weeks since prior substantial bone marrow irradiation * At least 6 months since prior craniospinal radiotherapy * At least 6 months since prior radiotherapy to 50% or more of the pelvis * At least 8 weeks since prior standard-fraction radiotherapy for patients with recurrent brain tumors unless there is biopsy proof of recurrent tumor * Prior radiosurgery within the past 9 months allowed provided there is documentation of progressive disease by biopsy, positron-emission tomography (PET) scan, or MR spectroscopy * No concurrent radiotherapy * More than 1 week since prior CYP3A4 inhibitors * More than 4 weeks since prior CYP3A4 inducers * More than 5 days since prior proton-pump inhibitors * More than 2 days since prior H_2 blockers * No prior erlotinib * No concurrent enzyme-inducing anticonvulsants * No concurrent proton-pump inhibitors * No concurrent H2 blockers * No other concurrent investigational agents * Concurrent antacids allowed provided the antacid is not administered 2 hours before, during, and 2 hours after erlotinib administration


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Patients receive oral erlotinib once daily on days 1-28. Beginning with course 2, patients also receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 23 courses in the absence of disease progression or unacceptable toxicity.

Given orally (PO)

Given PO

Correlative studies

Correlative studies
Study Objectives
Primary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
COG Phase I ConsortiumArcadia, United StatesSee the location

CompletedOne Study Center
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