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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms, Metastases

Thank you

Trial Information

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


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,

- 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.

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,

- 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,

- Patients must not have had unstable angina or myocardial infarction in the past 6
months,

- Patients must not have serious cardiac arrhythmia or symptomatic congestive heart
failure >= Grade II (NYHA classification),

- Patients must not have a history of prolonged QT, QTc > 470 ms (Bazett’s correction)
at entry, or history of torsade de pointes,

- Patients must not have recent history (<= 12 months) of active or chronic viral
hepatitis,

- Patients must not have organ allografts,

- Patients must not have known history of HIV positivity,

- Patients must not have a history of hypersensitivity to sulfonamides,

- Patients must not have a history of uncontrolled seizures,

- Patients must not have had a prior malignancy, other than carcinoma in situ of the
cervix or nonmelanoma skin cancer, unless the prior malignancy was diagnosed and
definitively treated >= 5 years previously with no subsequent evidence of recurrence,
or

- Patients must not have other significant disease or disorders that, in the
Investigator’s opinion, would exclude the patient from the study.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Principal Investigator

Sandra Silberman, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

E7070-A001-211

NCT ID:

NCT00080197

Start Date:

February 2004

Completion Date:

May 2005

Related Keywords:

  • Breast Neoplasms
  • Metastases
  • Breast Cancer
  • Cancer of the Breast
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

Name

Location

Hinsdale, Illinois  60521
New Britain, Connecticut  06052
Alexandria, Minnesota  56308
Birmingham, Alabama  35294
Phoenix, Arizona  85012
Miami, Florida  33176
Columbia, Missouri  65203
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
McLean, Virginia  22101
Kansas City, Kansas  66160
Denver, Colorado  
Charlotte, North Carolina  
Indianapolis, Indiana  
Charleston, South Carolina  
Tulsa, Oklahoma