Clinical trial NCT00067314: Study in Women With Metastatic Breast Cancer Whose Cancer Has Gotten Worse After Anthracycline and Taxane Therapy
Official title: A Phase II Study Of Intravenous Edotecarin (PHA-782615) In Patients With Anthracycline- And Taxane Resistant Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Neoplasm Metastasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2003-08-18
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: To assess the anti-tumor activity of single-agent Edotecarin by determining the objective response rate
Secondary outcomes:
measure: Time to tumor response (TAR)
measure: Duration of response (DR)
measure: Time to tumor progression (TTP)
measure: Time to treatment failure (TTF)
measure: Overall survival (OS)
measure: Clinical benefit
measure: ie, a composite profile of pain intensity
measure: analgesic consumption and performance status (pain and analgesic consumption to be measured as described in Purohit 1994 [18]
measure: performance status to be assessed using the Eastern Cooperative Oncology Group ([ECOG]) scale [Appendix 2]
measure: Overall safety profile characterized by type, frequency, severity (as graded by version 2.0 of the National Cancer Institute (NCI) Common Toxicity Criteria [CTC]
measure: [Appendix 3], timing and relationship to study therapy of adverse events and laboratory abnormalities.
measure: Plasma pharmacokinetic parameters
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Orange Village
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Westlake
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: East Bentleigh
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Brussel
country: Belgium
facility: Pfizer Investigational Site
city: Charleroi
country: Belgium
facility: Pfizer Investigational Site
city: Haine St. Paul
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Wilrijk
country: Belgium
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Toulouse Cedex
country: France
facility: Pfizer Investigational Site
city: Vandoeuvre Les Nancy
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: