NCT00077454

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Previously Treated Childhood Rhabdomyosarcoma
• Recurrent Childhood Brain Tumor
• Recurrent Childhood Cerebellar Astrocytoma
• Recurrent Childhood Cerebral Astrocytoma
• Recurrent Childhood Ependymoma
• Recurrent Childhood Malignant Germ Cell Tumor
• Recurrent Childhood Medulloblastoma
• Recurrent Childhood Rhabdomyosarcoma
• Recurrent Childhood Soft Tissue Sarcoma
• Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
• Recurrent Neuroblastoma
• Recurrent Osteosarcoma

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	Given orally (PO)
DRUG	temozolomide	Given PO
OTHER	pharmacological study	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-02-01
• Primary completion: 2007-09-01
• First posted: 2004-02-12
• Last updated: 2013-06-05

Locations

1 site across 1 country: United States