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 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT00245050
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following:
* Recurrent ovarian, fallopian tube, or peritoneal cavity cancer
* Metastatic breast cancer
* Advanced endometrial cancer
* Planning to receive chemotherapy with doxorubicin HCl liposome at a dose of 40 mg/m\^2
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Sex
* Not specified
Menopausal status:
* Not specified
Performance status
* Karnofsky 60-100%
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
Hepatic
* AST and ALT ≤ 2 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2 times ULN
* Bilirubin normal
Renal
* Creatinine ≤ 2.0 mg/dL
Cardiovascular
* Ejection fraction ≥ 50% by MUGA or 2-D echocardiogram
* No history of cardiac disease
* No New York Heart Association class II-IV heart disease
* No clinical evidence of congestive heart failure
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after completion of study treatment
* No active infection requiring antibiotics
* No history of hypersensitivity reaction attributed to a conventional formulation of doxorubicin HCl or doxorubicin HCl liposome and any of its components
* No other invasive malignancy within the past 5 years except nonmelanoma or basal cell skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
* At least 3 weeks since prior biologic or immunologic agents for this cancer
Chemotherapy
* Recovered from prior chemotherapy
* Alopecia or neuropathy allowed
* No prior doxorubicin HCl liposome
* Other concurrent chemotherapy allowed provided palmar-plantar erythrodysesthesia is not one of the side effects of the therapy
* No concurrent cytarabine, fluorouracil, liposomal daunorubicin, or capecitabine
* No concurrent pre-medication with corticosteroids as part of the chemotherapy regimen
Endocrine therapy
* See Chemotherapy
* At least 3 weeks since prior and no concurrent oral or topical corticosteroids
* At least 1 week since prior hormonal therapy for this cancer
* Concurrent hormone replacement therapy allowed
Radiotherapy
* At least 3 weeks since prior radiotherapy for this cancer and recovered
Surgery
* Recovered from prior surgery
Other
* At least 3 weeks since prior and no other concurrent forms of pyridoxine except what is included in a multivitamin
* No prior anticancer treatment that contraindicates study treatment
* No concurrent amifostine or other protective agents
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00245050
Study Brief:
Protocol Section:
NCT00245050