Lapatinib and Vinorelbine in Treating Patients With Advanced Solid Tumors

Summary

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

DRUG

lapatinib ditosylate

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)

DRUG

vinorelbine ditartrate

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)

GENETIC

comparative genomic hybridization

Molecular correlative study

GENETIC

cytogenetic analysis

Molecular correlative study

GENETIC

gene expression analysis

Molecular correlative study

GENETIC

mutation analysis

Molecular correlative study

GENETIC

polymerase chain reaction

Molecular correlative study

GENETIC

polymorphism analysis

Molecular correlative study

GENETIC

proteomic profiling

Molecular correlative study

GENETIC

reverse transcriptase-polymerase chain reaction

Molecular correlative study

OTHER

immunohistochemistry staining method

Molecular correlative study

OTHER

laboratory biomarker analysis

Molecular correlative study

DRUG

lapatinib ditosylate

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)

DRUG

Vinorelbine ditartrate

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)

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of California, Davis

  lead OTHER

Principal Investigators

• Helen K. Chew, MD · University of California, Davis

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2005-12-31

Primary Completion

2009-04-30

Completion

2011-12-31

Countries

• United States

Study Locations