S0528 Lapatinib and Everolimus in Treating Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Lapatinib; Sirolimus

Criteria

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