NCT00316407

Brief Summary

The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_1

Geographic Reach
1 country

2 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

August 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2006

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 18, 2011

Status Verified

March 1, 2010

Enrollment Period

4.3 years

First QC Date

April 18, 2006

Last Update Submit

February 16, 2011

Conditions

Ovarian Epithelial Cancer Stage IIIStage IV Ovarian CancerStage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Toxicity

    1 year

Secondary Outcomes (1)

  • Objective response (PR or CR)

    1 year

Interventions

lapatinib (GW572016)DRUG

1000 mg po qd

Also known as: Tykerb
CarboplatinDRUG

AUC 2 weekly x 3 of 4 week cycle

Also known as: Paraplatin
PaclitaxelDRUG

60 mg/m2 weekly x 3 of 4 week cycle

Also known as: Taxol

Eligibility Criteria

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

You may qualify if:

  • Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma patients.
  • Stage IV metastatic breast cancer patients who have failed no more than four previous chemotherapies for Stage IV disease.
  • Ability to swallow and retain oral medications.
  • Measurable disease

You may not qualify if:

  • Treatment with previous weekly carboplatin and paclitaxel.
  • No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and cetuximab.
  • No concomitant requirement for medication classification as CYP3A4 inducers or inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131, United States

Location

Swedish Medical Center Cancer Institute

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian EpithelialOvarian NeoplasmsBreast Neoplasms

Interventions

LapatinibCarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Saul Rivkin, MD

    Swedish Medical Center Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 20, 2006

Study Start

August 1, 2005

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

February 18, 2011

Record last verified: 2010-03

Locations

US(2)