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:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT00006260
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically proven progressive metastatic breast cancer
* Measurable disease
* Any lesion measurable in 2 dimensions
* Hepatic metastases if the sum of the measurements below the costal margin in the midclavicular line and the tip to the xiphoid process is greater than 5 cm during quiet respiration
* Hepatic defects that are clearly measurable by radionuclide, CAT, or MRI scans
* Bone metastases are not considered measurable disease
* Evaluable disease allowed if measurable disease also present
* No brain metastases, carcinomatous meningitis, or spinal cord compression
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* Not specified
Menopausal status:
* Not specified
Performance status:
* ECOG 0-2
Life expectancy:
* At least 3 months
Hematopoietic:
* Hemoglobin at least 10 g/dL
* WBC at least 4,000/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
Renal:
* Creatinine no greater than 1.5 mg/dL
* No bladder outlet obstruction
Cardiovascular:
* No symptomatic cardiovascular disease (e.g., congestive heart disease) or inability to tolerate a fluid load
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection
* No prior malignancies except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No greater than 1 prior biologic response modifier treatment for metastatic disease
Chemotherapy:
* No greater than 1 prior chemotherapy regimen for metastatic disease allowed
* Patients who relapsed during or within 6 months after adjuvant chemotherapy are considered to have failed 1 regimen
* Patients who relapsed more than 6 months after adjuvant chemotherapy are considered to not have had a prior regimen
* Greater than 4 weeks since prior chemotherapy (greater than 6 weeks for mitomycin or nitrosoureas) and recovered
* No prior cisplatin, etoposide, or ifosfamide
Endocrine therapy:
* Prior medical or surgical hormonal therapy allowed
Radiotherapy:
* Prior radiation therapy to areas of measurable disease allowed if indicator lesion increased in size by greater than 25% after treatment
* Recovered from effects of prior radiotherapy
Surgery:
* Recovered from effects of major surgery
Other:
* At least 7 days since prior nephrotoxic drugs (e.g., aminoglycosides, diuretics, lithium, intravenous contrast, or nonsteroidal antiinflammatory drugs)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00006260
Study Brief:
Protocol Section:
NCT00006260