NCT00513058

Brief 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 and vinorelbine in treating women with HER2-overexpressing locally advanced or metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Jun 2007

Typical duration for phase_1 breast-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

2.9 years

First QC Date

August 6, 2007

Last Update Submit

January 13, 2014

Conditions

Breast Cancer

Keywords

metastatic breast canceradvanced breast cancer

Outcome Measures

Primary Outcomes (1)

  • Toxicity as assessed by NCI CTCAE v3.0

    during the first cycle of treatment

Secondary Outcomes (2)

  • Pharmacokinetic interactions between vinorelbine ditartrate (oral or IV) and lapatinib ditosylate

    during the first cycle of treatment

  • Tumor response as assessed by RECIST criteria after every 2 courses

    during 6 months

Study Arms (1)

lapatinib + vinorelbine

EXPERIMENTAL

* starting with loading dose of lapatinib per os for 7 days * then, combining lapatinib (oral daily continuous) + vinorelbine (intravenous, day 1 and 8 every 3 weeks)

Drug: LapatinibDrug: vinorelbine

Interventions

LapatinibDRUG

Dose level (DL) 1 : 750 mg/d DL2, DL3, DL4: 1000 mg/d DL5, DL7, DL8: 1250 mg/d DL6: 1500 mg/d

Also known as: TYVERB
lapatinib + vinorelbine
vinorelbineDRUG

DL1, DL2: 20 mg/m2 DL3: 22.5 mg/m2 DL4, DL5, DL6: 25 mg/m2 DL7: 27.5 mg/m2 DL8: 30 mg/m2

Also known as: NAVELBINE
lapatinib + vinorelbine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Menopausal status not specified
  • Patients must have an estimated survival of at least 3 months
  • WHO performance status (ECOG) 0-2
  • Hemoglobin ≥ 9 g/dL
  • ANC ≥ 1,500/mm³
  • Platelets ≥ 100,000/mm³
  • Total bilirubin ≤ 2.5 mg/dL
  • ALT and AST ≤ 3 times upper limit of normal
  • Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 40 mL/min
  • LVEF ≥ 50% (echographic or isotopic method)
  • Potentially reproductive patients must agree to use an effective contraceptive method while on study treatment
  • Patients must be affiliated with a Social Security system

You may not qualify if:

  • Uncontrolled cardiac pathology
  • Dysphagia or inability to swallow the vinorelbine ditartrate soft capsules
  • Malabsorption syndrome or disease significantly affecting gastrointestinal function
  • Preexisting neuropathy (grade ≥ 2)
  • Pregnant women, women who are likely to become pregnant, or women who are breastfeeding
  • Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Individuals deprived of liberty
  • Prior major resection of stomach or proximal bowel that could affect absorption of oral drugs
  • Prior vinorelbine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Centre de Lutte Contre le Cancer Georges-Francois Leclerc

Dijon, 21079, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Institut Curie Hopital

Paris, 75248, France

Location

Centre Rene Huguenin

Saint-Cloud, 92211, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

LapatinibVinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesIndolizidinesIndolizines

Study Officials

  • Pierre Fumoleau, MD, PhD

    Centre Georges Francois Leclerc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 8, 2007

Study Start

June 1, 2007

Primary Completion

May 1, 2010

Study Completion

April 1, 2012

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

FR(5)