NCT00067314

Brief Summary

This international study will study how metastatic breast cancer responds to the investigational drug treatment, what are the side effects of the investigational drug when given to women with metastatic breast cancer and how often do these side effects occur. The study will also analyze how fast investigational drug and its breakdown products are cleared from the blood in these patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2003

Typical duration for phase_2

Geographic Reach
4 countries

19 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, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

4 years

First QC Date

August 15, 2003

Last Update Submit

January 13, 2012

Conditions

Breast NeoplasmsNeoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

  • To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate

Secondary Outcomes (12)

  • Time to tumor response (TAR)

  • Duration of response (DR)

  • Time to tumor progression (TTP)

  • Time to treatment failure (TTF)

  • Overall survival (OS)

  • +7 more secondary outcomes

Interventions

EdotecarinDRUG

Eligibility Criteria

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

You may qualify if:

  • Locally advanced or metastatic breast cancer not amenable to surgery or radiation with curative intent
  • Must have received any chemotherapy regimen in the past
  • Evidence of tumor resistance to last chemotherapy defined as progression after 6 months of previous chemotherapy for advanced disease
  • Must have measurable (by imaging techniques) disease
  • Adequate bone marrow, liver and renal function
  • Must provide evidence of informed consent and willingness and ability to comply with scheduled visits, treatment plan and study procedures.

You may not qualify if:

  • Received more than 2 prior chemotherapy regimens for metastatic disease
  • Received in the past another drug of the same class as the investigational drug, i.e. topoisomerase I inhibitor
  • Enrolled in another clinical intervention study
  • Pregnancy, breast feeding, fertile women refusing to use reliable contraceptive methods
  • Cardiac or thrombotic event in the last 12 months
  • Brain metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Pfizer Investigational Site

Manhasset, New York, 11030, United States

Location

Pfizer Investigational Site

New York, New York, 10021, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44106, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44121, United States

Location

Pfizer Investigational Site

Orange, Ohio, 44122, United States

Location

Pfizer Investigational Site

Westlake, Ohio, 44145, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37203, United States

Location

Pfizer Investigational Site

East Bentleigh, Victoria, 3165, Australia

Location

Pfizer Investigational Site

Parkville, Victoria, 3050, Australia

Location

Pfizer Investigational Site

Brussels, 1090, Belgium

Location

Pfizer Investigational Site

Charleroi, B-6000, Belgium

Location

Pfizer Investigational Site

Haine-Saint-Paul, 7100, Belgium

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Wilrijk, 2610, Belgium

Location

Pfizer Investigational Site

Dijon, 21034, France

Location

Pfizer Investigational Site

Montpellier, 34059, France

Location

Pfizer Investigational Site

Paris, 75015, France

Location

Pfizer Investigational Site

Toulouse, 31052, France

Location

Pfizer Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

edotecarin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2003

First Posted

August 18, 2003

Study Start

June 1, 2003

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations

AU(2)US(7)BE(5)FR(5)