S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma
Recruitment status was Active, not recruiting
Tracking Information | |||||||||
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First Received Date ICMJE | July 13, 2006 | ||||||||
Last Updated Date | July 19, 2011 | ||||||||
Start Date ICMJE | September 2006 | ||||||||
Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Maximum tolerated dose of lapatinib and everolimus (Part I) [ Designated as safety issue: Yes ] | ||||||||
Original Primary Outcome Measures ICMJE |
Maximum tolerated dose of lapatinib and everolimus (Part I) | ||||||||
Change History | Complete list of historical versions of study NCT00352443 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
Pharmacokinetics (Part II) [ Designated as safety issue: No ] | ||||||||
Original Secondary Outcome Measures ICMJE |
Pharmacokinetics (Part II) | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma | ||||||||
Official Title ICMJE | Phase I Study Evaluating the Combination of Lapatinib (GW572016; NSC-727989) and Everolimus (RAD001) in Patients With Advanced Solid Tumors | ||||||||
Brief Summary | RATIONALE: Lapatinib and everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Everolimus may also stop the growth of cancer cells by blocking blood flow to the cancer. Giving lapatinib together with everolimus may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib and everolimus in treating patients with advanced solid tumors or non-Hodgkin's lymphoma. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study followed by a randomized study. Initial patients enrolled on the study are treated in part I. After the maximum tolerated dose (MTD) is determined in part I, subsequent patients are enrolled and treated in part II.
Cohorts of 3-6 patients receive escalating doses of everolimus and lapatinib until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients in part II undergo blood collection periodically for correlative biomarker and pharmacokinetic studies. After finishing treatment, patients are followed periodically for 28 days. PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | Phase 1 | ||||||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | |||||||||
Publications * | Hoban CJ, Hoering A, Synold TW, et al.: Phase I evaluation of lapatinib and everolimus in patients with advanced malignancies: Southwest Oncology Group trial S0528. [Abstract] J Clin Oncol 27 (Suppl 15): A-3553, 2009. | ||||||||
* 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 | Active, not recruiting | ||||||||
Estimated Enrollment ICMJE | 48 | ||||||||
Completion Date | |||||||||
Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT00352443 | ||||||||
Other Study ID Numbers ICMJE | CDR0000486867, U10CA032102, S0528 | ||||||||
Has Data Monitoring Committee | |||||||||
Responsible Party | Laurence Baker, DO, SWOG | ||||||||
Study Sponsor ICMJE | Southwest Oncology Group | ||||||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
Investigators ICMJE |
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Information Provided By | Southwest Oncology Group | ||||||||
Verification Date | August 2009 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |