Erlotinib and Temozolomide in Treating Young Patients With Recurrent or Refractory Solid Tumors

Last Update Posted : 2013-06-05

The aim of the trial

This phase I trial is studying the side effects and best dose of erlotinib when given with temozolomide in treating young patients with recurrent or refractory solid tumors. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving erlotinib with temozolomide may kill more tumor cells.

Country: United States,
Locations: Arcadia,
Trial Type: Interventional
Trial Phase: Phase 1,
Trial Status: Completed
Minimum age: -
Maximum age: 21 Years
Key Contact: ----
Clinical Trial ID: NCT00077454

URL: https://clinicaltrials.gov/ct2/show/record/NCT00077454

Key Information

How the treatment works

Given orally (PO)
Visit our drugs and interventions page to find out more about this treatment, including how it works and what it’s used for.

Who is the trial for?

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 erlo

Disclaimer

ONTEX is intended to supplement, not replace, your healthcare team. Patients should always discuss a clinical trial with their healthcare team. If a patient is eligible for a trial the trial team will be able to provide more in-depth information about the trial so the patient can make an informed decision before taking part. Trial information has been sourced from www.clinicaltrials.gov. The content is then reviewed weekly by the Osteosarcoma Now team. All the trials also have a patient-friendly summary and key information section written by the team at Osteosarcoma Now. We have also included a description of the medications being used in the trial and summarised the inclusion and exclusion criteria in the ‘who is this trial (not) for’ sections. To the best of our knowledge the clinical trial database is up-to-date and accurate.However, we cannot assume any liability for the accuracy or completeness of the information.

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