Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-24 @ 9:47 PM
NCT ID:
NCT00020332
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically confirmed stage III or IV adenocarcinoma of the breast
* Phase I:
* Evaluable disease allowed
* Phase II:
* At least 1 site of measurable disease
* No bone metastasis as only site of disease
* No carcinomatous meningitis or brain metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Male or female
Menopausal status:
* Not specified
Performance status:
* ECOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* No active coagulopathy requiring therapeutic anticoagulation
Hepatic:
* Bilirubin no greater than upper limit of normal (ULN)
* SGOT no greater than 1.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
* No Gilbert's disease
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* Left ventricular ejection fraction at least 50% without clinical signs or symptoms of heart failure
* No uncontrolled hypertension (sustained systolic blood pressure (BP) greater than 180 mm Hg or diastolic BP greater than 100 mm Hg)
* No uncontrolled cardiac arrhythmia
* No myocardial infarction within the past year
* No significant ischemia or valvular heart disease
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No medical or psychiatric condition that would increase risk
* No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanomatous skin cancer
* No grade 2 or greater peripheral neuropathy
* No diabetes mellitus with a fasting blood sugar greater than 200 mg/dL
* No active unresolved infection
* No serious concurrent medical illness
* No history of hypersensitivity reaction to products containing polysorbate 80 (Tween 80)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior flavopiridol
* Prior adjuvant chemotherapy for advanced disease allowed if within 6 months of diagnosis of metastatic disease
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea or 8 weeks for UCN-01) and recovered
* Phase I:
* Any number of prior chemotherapy regimens for metastatic carcinoma of the breast allowed
* Phase II:
* No more than 2 prior chemotherapy regimens for metastatic carcinoma of the breast
Endocrine therapy:
* Prior hormonal therapy in the metastatic or adjuvant setting allowed
* At least 2 weeks since prior hormonal therapy and no evidence of disease improvement by radiography after therapy
* Concurrent corticosteroids allowed if for study premedication or hypersensitivity reactions/adverse events
Radiotherapy:
* No concurrent radiotherapy
Surgery:
* Not specified
Other:
* No other concurrent antineoplastic therapies
* No other concurrent investigational drugs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00020332
Study Brief:
Protocol Section:
NCT00020332