An Open-Label Phase II Study of E7070 in Metastatic Breast Cancer Patients Previously Treated With an Anthracycline, a Taxane, and Capecitabine

Eisai Inc.0 sites250 target enrollmentFebruary 2004

ConditionsBreast Neoplasms Metastases

DrugsE7070

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Neoplasms
Sponsor: Eisai Inc.
Enrollment: 250
Primary Endpoint: Objective Response Rate
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2004

End Date

May 2005

Last Updated

19 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Eisai Inc.

Eligibility Criteria

Inclusion Criteria

•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,

Exclusion Criteria

•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,