Study to Evaluate the Efficacy, Safety, and Tolerability of E7070 in Metastatic Breast Cancer Patients
An Open-Label Phase II Study of E7070 in Metastatic Breast Cancer Patients Previously Treated With an Anthracycline, a Taxane, and Capecitabine
1 other identifier
interventional
250
2 countries
35
Brief Summary
The purpose of this study is to determine if E7070 is an efficacious, safe, and tolerable treatment for patients with metastatic breast cancer who have failed, or could not tolerate, prior treatments with an anthracycline, a taxane, and capecitabine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2004
Shorter than P25 for phase_2
35 active sites
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
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 24, 2004
CompletedFirst Posted
Study publicly available on registry
March 25, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedOctober 11, 2006
October 1, 2006
March 24, 2004
October 10, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response Rate
Secondary Outcomes (6)
Duration of Response
Time-to-Progression
Overall Survival
Safety
Tolerability
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Patients must be female,
- Patients must have histologically or cytologically confirmed metastatic breast cancer,
- Patients must either have tumors that are resistant/refractory to chemotherapy with an anthracycline, a taxane, capecitabine, and appropriate Herceptin therapy, or tumors that cannot be treated with these agents due to patient's treatment toxicity; therefore, patients must have received 2 prior chemotherapies but no more than 3 prior chemotherapies in the metastatic setting,
- Patients must have at least one uni-dimensionally measurable lesion according to the RECIST criteria in at least one site that has not been irradiated,
- Patients must be aged \>= 18 years,
- Patients must have a Karnofsky Performance Status of \>= 70%,
- Patients must have a life expectancy of \>= 3 months,
- Patients must have adequate renal function as evidenced by serum creatinine \<= 1.5 mg/dL, or if \> 1.5 but \<= 1.8 mg/dL, then a creatinine clearance of \>= 45 mL/min,
- Patients must have adequate bone marrow function as evidenced by absolute neutrophil count of \>= 1.5 x 109/L, hemoglobin \>= 9.0 g/dL, and platelet count \>= 100 x 109/L,
- Patients must have adequate liver function as evidenced by bilirubin of \<= 1.5 times the upper limits of normal (ULN); alkaline phosphatase \<= 3 times ULN and alanine transaminase (ALT) and aspartate transaminase (AST) \<= 3 times ULN, unless related to liver metastasis, in which case \<= 5 x ULN,
- Patients must have serum electrolytes including calcium (corrected for albumin), magnesium, and potassium (corrected) within normal limits,
- Patients must be willing and able to complete the FACT-B questionnaire,
- Patients must be willing and able to comply with the study protocol for the duration of the study, and
- Patients must give written informed consent prior to any study specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.
You may not qualify if:
- Patients must not have metastatic disease that can be completely surgically resected,
- Patients who received adjuvant taxane must not have experienced disease progression within 12 months of beginning that therapy,
- Patients must not have received chemotherapy, hormonal therapy, or Herceptin within 2 weeks of E7070 treatment start and must have recovered from any chemotherapy-related or other therapy-related toxicity at study entry,
- Patients must not have received investigational drugs including immunotherapy, gene therapy, or other biologic therapy; antineoplastic therapy; or radiation therapy (other than required for palliation of bone pain or chest ulceration) within 2 weeks of E7070 treatment,
- Patients must not have received prior treatment with Mitomycin C or nitrosoureas,
- Patients must not have undergone high dose chemotherapy with hematopoietic stem cell rescue,
- Patients must not have untreated brain metastases (Patients who have been treated for central nervous system (CNS) metastases must be asymptomatic and radiologically stable \[not receiving radiation\] and must not have been receiving steroids for 4 weeks prior to entry.
- Patients without known CNS metastases who are symptomatic for CNS metastasis must be evaluated with a CT scan or MRI scan prior to E7070 treatment.),
- Patients must not have had major surgery without full recovery within 4 weeks of E7070 treatment start,
- Patients must not have pulmonary lymphatic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen,
- Patients must not have leptomeningeal metastasis,
- Patients must not have evidence of clinically relevant ascites or pleural effusion requiring more than one isolated paracentesis or pleurocentesis per month prior to study start,
- Patients must not be expected to require more than one isolated paracentesis or pleurocentesis per month during the study for the treatment of clinically relevant ascites or pleural effusion,
- Patients must not be pregnant or breast-feeding and must practice adequate contraception if not surgically sterile,
- Patients must not have severe medically uncontrolled intercurrent illness/infection,
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (35)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Hoover, Alabama, United States
Unknown Facility
Sedona, Arizona, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Torrington, Connecticut, United States
Unknown Facility
Fort Myers, Florida, United States
Unknown Facility
Ocoee, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Skokie, Illinois, United States
Unknown Facility
Urbana, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Overland Park, Kansas, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
St Louis, Missouri, United States
Unknown Facility
Albany, New York, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Kettering, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Tulsa, Oklahoma, United States
Unknown Facility
Clairton, Pennsylvania, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Wexford, Pennsylvania, United States
Unknown Facility
Greenville, South Carolina, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Fort Worth, Texas, United States
Unknown Facility
Fredericksburg, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Irving, Texas, United States
Unknown Facility
Tyler, Texas, United States
Unknown Facility
Fairfax, Virginia, United States
Unknown Facility
Spokane, Washington, United States
Unknown Facility
Vancouver, Washington, United States
Unknown Facility
Edmonton, Alberta, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sandra Silberman, M.D.
Eisai Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 24, 2004
First Posted
March 25, 2004
Study Start
February 1, 2004
Study Completion
May 1, 2005
Last Updated
October 11, 2006
Record last verified: 2006-10