SWOG clinical trial number
S0528
Phase I Study Evaluating the Combination of Lapatinib (GW572016; NSC-727989; IND-75,093) and Everolimus (RAD001; NSC-733504; IND-75,093) in Patients with Advanced Solid Tumors
Closed
Phase
Accrual
100%
Published
Abbreviated Title
Phase I Study of Lapatinib and Everolimus in Advanced Solid Tumors
Activated
09/01/2006
Closed
08/25/2009
Participants
Limited: Institutions Listed on the Title Page
Research committees
Early Therapeutics & Rare Cancers
Treatment
Lapatinib
Everolimus
Eligibility Criteria Expand/Collapse
Pts must have cytologically or pathologically cancer of advanced stage; measurable or non-measurable disease; Pts with brain mets must be on stabe or decreasing corticosteroids and seizure free for 30 days; Pts with untreated brain mets are not eligible; Zubrod PS 0-2; 18 yrs of age or older; ANC >=1.5; Platelets >=100; SGOT/SGPT <= 2.5xIULN; Bili <= IULN; Pts with liver mets must have SGOT/SGPT <= 5xIULN; Patients must not have current active hepatic or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones); adequate renal function (serum creatinine <= IULN; or measured creatinine > 60 mL/min; or estimated creatinine > 60 mL/min); cardiac ejection fraction within inst. range of normal; pts must be able to swallow meds.; pts. with feeding tubes are not eligible; no prior treatment with study drugs; no major surgery, chemo or radiotherapy within 14 days; no nitrosoureas or mitomycin c within 42 days; no investigational agents within 28 days; Pts known to be HIV-pos. are not eligible; Pts that are pregnant or nursing are not eligible; Pts with uncontrolled intercurrent illness are not eligible
Publication Information Expand/Collapse
2021
Drug-drug interactions in subjects enrolled in SWOG trials of oral chemotherapy
PMid: PMID33771105 | PMC number: PMC7995697
2019
Prevalence of drug-drug interactions in oncology patients enrolled in two completed SWOG clinical trials
2013
PMid: PMID24057042 | PMC number: PMC4072025
2009
Phase I evaluation of lapatinib and everolimus in patients (pts) with advanced malignancies: Southwest Oncology Group trial (S0528)
Other Clinical Trials
SWOG Clinical Trial Number
CTSU/AOST2032
AOST2032: A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma
Research Committee(s)
Early Therapeutics & Rare Cancers
Activated
02/17/2023
Open
SWOG Clinical Trial Number
CTSU/AOST2031
AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma
Research Committee(s)
Early Therapeutics & Rare Cancers
Activated
02/15/2022
Open
SWOG Clinical Trial Number
S2012
Randomized Phase II/III Trial of First Line Platinum/Etoposide with or without Atezolizumab (NSC#783608) in Patients with Poorly Differentiated Extrapulmonary Small Cell Neuroendocrine Carcinomas (NEC)
Research Committee(s)
Early Therapeutics & Rare Cancers
Activated
12/02/2021
Accrual
34%
Open
Phase