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CompletedPhase 2ACTRN12611000418976

Investigation of the efficacy of lapatinib plus temozolomide combination, in recurrent brain tumors. A phase I/II study.

Patients with recurrent high grade gliomas treated with lapatinib plus temozolomide combination to investigate the safety and efficacy of the combination

Sponsor

Hellenic Cooperative Oncology Group

Enrollment

66 participants

Start Date

Jan 12, 2009

Study Type

Interventional

Conditions

patients with recurrent or refractory gliomas

Summary

This study will integrate an initial phase I dose-escalation part aimed at documenting the safety profile and recommended dose of lapatininb in combination with temozolomide in patients with recurrent refractory glioblastoma multiforme. It will be followed by a phase II open-label study to evaluate the efficacy of lapatinib /temozolomide combination in patients with recurrent high grade gliomas. Patients will be treated with the combination until disease progression, unacceptable toxicity or consent withdrawal.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This Phase I/II trial tests a combination of lapatinib (a targeted cancer drug) and temozolomide (chemotherapy) for adults aged 18+ with recurrent high-grade brain tumours (glioblastoma or anaplastic astrocytoma) that have returned after initial treatment with radiation and temozolomide.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Phase I: In the phase I study patients will be enrolled in cohorts of 3. They will receive fixed dose temozolomide [200 mg/m2 orally (po) once daily for 5 days] in cycles of 28 days and escalating dos

Phase I: In the phase I study patients will be enrolled in cohorts of 3. They will receive fixed dose temozolomide [200 mg/m2 orally (po) once daily for 5 days] in cycles of 28 days and escalating doses of lapatinib. The starting dose of lapatinib will be 1000 mg administered orally (po) once daily (OD) every day of the 28 day cycle. Three dose levels of lapatinib will be explored (1000, 1250 and 1500 mg). Patients will receive lapatinib/ temozolomide combination until disease progression or unacceptable toxicity. Cohorts of 3 patients will receive escalating doses of lapatinib until the maximum tolerated dose is determined (MTD) as recorded in week 4 of treatment. Phase II: Temozolomide 200 mg/m2 orally (po) once daily for 5 days will be used along with Lapatinib 1000 mg orally (po) once daily (dose as defined from phase I). The cycle duration is 28 days. The treatment will continue until disease progression, unacceptable toxicity or consent withdrawal.

Locations(1)

Greece

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ACTRN12611000418976