Erlotinib and Temozolomide in Treating Young Patients With Recurrent or Refractory Solid Tumors
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First Received Date ICMJE | February 10, 2004 | ||||||||
Last Updated Date | December 28, 2010 | ||||||||
Start Date ICMJE | February 2004 | ||||||||
Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||||||
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Change History | Complete list of historical versions of study NCT00077454 on ClinicalTrials.gov Archive Site | ||||||||
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Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Erlotinib and Temozolomide in Treating Young Patients With Recurrent or Refractory Solid Tumors | ||||||||
Official Title ICMJE | 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 | ||||||||
Brief Summary | RATIONALE: 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. PURPOSE: 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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
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).
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.
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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 1 | ||||||||
Study Design ICMJE | Primary Purpose: Treatment | ||||||||
Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | |||||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Enrollment ICMJE | |||||||||
Completion Date | |||||||||
Primary Completion Date | April 2006 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||||||
Ages | up to 21 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States, Canada | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00077454 | ||||||||
Other Study ID Numbers ICMJE | CDR0000350336, COG-ADVL0214, NCI-04-C-0256 | ||||||||
Has Data Monitoring Committee | |||||||||
Responsible Party | |||||||||
Study Sponsor ICMJE | Children's Oncology Group | ||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
Investigators ICMJE |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | November 2010 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |