NCT00189579

Brief Summary

The purpose of this study is to evaluate whether or not the addition of Herceptin may be of benefit to a standard regimen of carboplatin-paclitaxel.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_2 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

August 17, 2007

Status Verified

August 1, 2007

First QC Date

September 12, 2005

Last Update Submit

August 16, 2007

Conditions

Ovarian Cancer

Keywords

HERCEPTINCarboplatinPaclitaxelRelapse

Interventions

HerceptinDRUG

Eligibility Criteria

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

You may qualify if:

  • years or older; patients with histologically proven diagnosis of ovarian cancer.
  • Patients with metastatic disease and an overexpression of HER2 (as determined by immunochemistry)
  • Patients who have progressed while receiving treatment, or within 6 months after completion of treatment. Patients must have received carboplatin and paclitaxel.
  • Patients who have received at minimum one line of chemotherapy
  • weeks minimum since last treatment with chemotherapy must have elapsed
  • Patients must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) or an assessable cancer antigen (CA) 125 \> 1.25 x upper limit of normal (ULN)
  • Patients must have ECOG of 2 or less
  • Left ventricular ejection fraction (LVEF) of 50% or better
  • Patients have given their signed and verbal consent

You may not qualify if:

  • Previous treatment with Herceptin or similar products affected growth factors (eg: Iressa)
  • Another experimental treatment in the previous 30 days
  • No overexpression of HER2 receptors
  • Patients having received high-dose chemotherapy or stem-cell interventions
  • Other cancers within the last 5 years
  • Patients with dyspnea at rest or requiring oxygen therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Hotel-Dieu

Paris, 75004, France

Location

MeSH Terms

Conditions

Ovarian NeoplasmsRecurrence

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Eric Pujade-Lauraine, MD, PhD

    Hopital Hotel-Dieu

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Completion

January 1, 2007

Last Updated

August 17, 2007

Record last verified: 2007-08

Locations

FR(1)