Lapatinib and Vinorelbine in Treating Patients With Advanced Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
University of California, Davis
Study ID
NCT00389922
Phase
PHASE1
Status
Completed

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

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

Interventions

  • lapatinib ditosylate — DRUG
    Given orally for 28 days per dose level (Dose level 1: 250mg; Dose level 2: 500mg; Dose level 3: 1000mg; Dose level 4: 1250mg; Dose level 5: 1500mg; Dose level 6: 1500mg)
  • vinorelbine ditartrate — DRUG
    Given IV Days 1, 8 and 15 per dose level (Dose level 1: 20mg/m2; Dose level 2: 20mg/m2; Dose level 3: 20mg/m2; Dose level 4: 20mg/m2; Dose level 5: 20mg/m2; Dose level 6: 25mg/m2)
  • comparative genomic hybridization — GENETIC
    Molecular correlative study
  • cytogenetic analysis — GENETIC
    Molecular correlative study
  • gene expression analysis — GENETIC
    Molecular correlative study
  • mutation analysis — GENETIC
    Molecular correlative study
  • polymerase chain reaction — GENETIC
    Molecular correlative study
  • polymorphism analysis — GENETIC
    Molecular correlative study
  • proteomic profiling — GENETIC
    Molecular correlative study
  • reverse transcriptase-polymerase chain reaction — GENETIC
    Molecular correlative study
  • immunohistochemistry staining method — OTHER
    Molecular correlative study
  • laboratory biomarker analysis — OTHER
    Molecular correlative study
  • lapatinib ditosylate — DRUG
    Given orally on Days 2-5, 9-12 and 16-25 per dose level (Dose level 1: 1250mg; Dose level 2: 1500mg; Dose level 3: 1500mg; Dose level 4: 1700mg)
  • Vinorelbine ditartrate — DRUG
    Given IV Days 1, 8 and 15 per dose level (Dose level 1: 20mg/m2; Dose level 2: 20mg/m2; Dose level 3: 25mg/m2; Dose level 4: 25mg/m2)

Study Details

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with vinorelbine may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of lapatinib when given together with vinorelbine in treating patients with advanced solid tumors.

Key Dates

Start date
Dec 31, 2005
Status verified
Apr 2012
Primary completion
Apr 30, 2009
Completion
Dec 31, 2011

Study Design

Enrollment
22 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A (Daily Dosing)
    Oral lapatinib given daily for 28 days plus IV vinorelbine given weekly (3 out of 4 weeks) Cohorts of 3-6 patients receive escalating doses of lapatinib ditosylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during course 1. At least 6 patients are treated at the MTD. Once the MTD of lapatinib has been determined, patients may be accrued to group B or to a separate pharmacokinetics cohort in group A.
  • Experimental: B (Intermittent Dosing)
    Oral lapatinib given days 2-5, 9-12 and 16-25 plus IV vinorelbine given weekly (3 out of 4 weeks) Cohorts of 3-6 patients receive escalating doses of lapatinib ditosylate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during course 1. At least 6 patients are treated at the MTD. Once the MTD of lapatinib has been determined, patients may be accrued to group B or to a separate pharmacokinetics cohort in group A.

Primary Outcome Measure

Toxicity as assessed by NCI CTCAE v3.0 [ Time Frame: Completion of study ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope Comprehensive Cancer CenterDuarteCalifornia91010-3000-
USC/Norris Comprehensive Cancer Center and HospitalLos AngelesCalifornia90089-9181-
University of California Davis Cancer CenterSacramentoCalifornia95817-
Seattle Cancer Care AllianceSeattleWashington98109-1023-

Find similar trials in Duarte, CA

By research site
City of Hope Comprehensive Cancer Center· Duarte, CAUSC/Norris Comprehensive Cancer Center and Hospital· Los Angeles, CAUniversity of California Davis Cancer Center· Sacramento, CASeattle Cancer Care Alliance· Seattle, WA

Related Studies