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

Part of paid clinical trials in Los Angeles, California.

Sponsor
SWOG Cancer Research Network
Study ID
NCT00352443
Phase
PHASE1
Status
Completed

Conditions

  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • everolimus — DRUG
    part 1: dose assigned by ETx online system PO days 1-28 daily part 2: cohort a: 5 mg PO days 1-28 part 2: cohort a: 1250 mg PO days 8-28 (cycle 1) days 1-28 (subsequent cycles)
  • lapatinib ditosylate — DRUG
    dose assigned by ETx online system PO days 1-28 daily part 2 cohort a: 1250 mg PO d 8-28 (cycle 1) days 1-28 (subsequent cycles) part 2 cohort b: 120 mg PO days 1-28 daily

Study Details

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.

Key Dates

Start date
Sep 30, 2006
Status verified
Mar 2015
Primary completion
Aug 31, 2007
Completion
Sep 30, 2013

Study Design

Enrollment
66 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: everolimus/lapatinib
    Part 1, dose finding: everolimus and lapatinib at assigned dose daily Part 2, cohort A: Everolimus MTD from Part I: 5 mg PO 1-28 Daily Lapatinib MTD from Part I: 1,250 mg PO Cycle 1, Daily Days 8-28\*\* Subsequent Cycles, Days 1-28 Part 2, cohort B: Lapatinib MTD from Part I: 1,250 mg PO 1-28 Daily Everolimus MTD from Part I: 5 mg PO Cycle 1, Daily Days 8-28\*\* Subsequent Cycles, Days 1-28

Primary Outcome Measure

Maximum tolerated dose of lapatinib and everolimus (Part I) [ Time Frame: 1 month ]

Locations (6)

FacilityCityStateZIPSite coordinators
USC/Norris Comprehensive Cancer Center and HospitalLos AngelesCalifornia90089-9181-
University of California Davis Cancer CenterSacramentoCalifornia95817-
University of Colorado Cancer Center at UC Health Sciences CenterAuroraColorado80045-
Lucille P. Markey Cancer Center at University of KentuckyLexingtonKentucky40536-0093-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-0942-
University Cancer Center at University of Washington Medical CenterSeattleWashington98195-6043-

Find similar trials in Los Angeles, CA

By research site
USC/Norris Comprehensive Cancer Center and Hospital· Los Angeles, CAUniversity of California Davis Cancer Center· Sacramento, CAUniversity of Colorado Cancer Center at UC Health Sciences Center· Aurora, COLucille P. Markey Cancer Center at University of Kentucky· Lexington, KYUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MIUniversity Cancer Center at University of Washington Medical Center· Seattle, WA

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