Lymphoma Clinical Trial
Official title:
Phase I Study Evaluating the Combination of Lapatinib (GW572016; NSC-727989) and Everolimus (RAD001) in Patients With Advanced Solid Tumors
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | September 2013 |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed advanced solid tumor or non-Hodgkin's lymphoma for which no curative options exist - Measurable or nonmeasurable disease - Patients with brain metastases who require corticosteroids or anticonvulsants must be on a stable or decreasing dose of corticosteroids and seizure free for 30 days prior to study entry - Patients with known brain metastases must have had brain irradiation (whole brain or gamma knife) - No untreated (non-irradiated) brain metastases PATIENT CHARACTERISTICS: - Zubrod performance status 0-2 - Absolute neutrophil count = 1,500/mm³ - Platelet count = 100,000/mm³ - SGOT or SGPT = 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) - Bilirubin normal - Creatinine normal OR creatinine clearance > 60 mL/min - Cardiac ejection fraction normal by echocardiogram or MUGA - Able to swallow enteral medications - No feeding tubes - No intractable nausea or vomiting - No gastrointestinal (GI) tract disease resulting in an inability to take oral medication - No current active hepatic or biliary disease with the exception of Gilbert's syndrome or asymptomatic gallstones - No malabsorption syndrome - No requirement for IV alimentation - No uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis) - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or everolimus, including other quinazoline compounds, such as gefitinib and erlotinib, or other rapamycins, such as sirolimus and temsirolimus - No known HIV positivity - No concurrent uncontrolled illness, including, but not limited to, any of the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Myocardial infarction or cerebrovascular accident within the past 3 months - Uncontrolled diarrhea - Psychiatric illness or social situation that would preclude compliance with study requirements - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Willing to undergo pharmacokinetic (PK) sampling and blood collection for PK and correlative studies (for patients enrolled in part II) PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Recovered from prior therapy - No prior lapatinib or everolimus - No prior surgical procedures affecting absorption - More than 14 days since prior major surgery, chemotherapy (42 days for nitrosoureas or mitomycin C), or radiotherapy - More than 28 days since prior investigational agents - At least 7 days since prior and no concurrent CYP3A4 inhibitors - At least 14 days since prior and no concurrent CYP3A4 inducers - At least 14 days since prior and no concurrent herbal or dietary supplements - No concurrent chemotherapy, hormone therapy, radiotherapy, immunotherapy, live vaccines or any other anticancer therapy - Concurrent luteinizing hormone-releasing hormone agonists allowed - Concurrent bisphosphonates or epoetin alfa or its analogue allowed - No concurrent gastric H2 blockers (e.g., cimetidine, ranitidine, nizatidine, famotidine) or proton pump inhibitors (e.g., omeprazole, esomeprazole, rabeprazole, pantoprazole, or lansoprazole) - Antacids allowed provided they are not administered within 1 hour before and after lapatinib - No concurrent glucocorticoids or immunosuppressants |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | University of Colorado Cancer Center at UC Health Sciences Center | Aurora | Colorado |
United States | Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | University of California Davis Cancer Center | Sacramento | California |
United States | University Cancer Center at University of Washington Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Southwest Oncology Group | National Cancer Institute (NCI) |
United States,
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose of lapatinib and everolimus (Part I) | 1 month | Yes | |
Secondary | Pharmacokinetics (Part II) | 1 month | No |
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