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

LA Marcath;C Finley;S-F Wong;DL Hertz BMC Cancer Mar 26;21(1):324. doi: 10.1186/s12885-021-08050-w

PMid: PMID33771105 | PMC number: PMC7995697

2019

Prevalence of drug-drug interactions in oncology patients enrolled in two completed SWOG clinical trials

L Marcath;C Finley;S-F Wong;D Hertz American College of Clinical Pharmacology (9/15-17/2019, Chicago, IL), poster

2013

Phase I study evaluating the combination of lapatinib and everolimus in patients with advanced cancers: SWOG study S0528

S Gadgeel;D Lew;T Synold;P LoRusso;V Chung;S Christensen;D Smith;L Kingsbury;A Hoering;R Kurzrock Cancer Chemotherapy and Pharmacology 72(5):1089-1096;

PMid: PMID24057042 | PMC number: PMC4072025

2009

Phase I evaluation of lapatinib and everolimus in patients (pts) with advanced malignancies: Southwest Oncology Group trial (S0528)

CJ Hoban;A Hoering;TW Synold;V Chung;DR Gandara;AF Schott;L Kingsbury;D Lew;P LoRusso;SM Gadgeel Journal of Clinical Oncology 27:15s, abst. 3553 (poster)

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