Phase
Condition
Digestive System Neoplasms
Vaginal Cancer
Peritoneal Cancer
Treatment
N/AClinical Study ID
Female
Study Summary
Eligibility Criteria
Inclusion
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
Study Design
Study Description
Connect with a study center
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio 44106-5065
United StatesSite Not Available
Geauga Regional Hospital
Cleveland, Ohio 44024
United StatesSite Not Available
Lake/University Ireland Cancer Center
Cleveland, Ohio 44060
United StatesSite Not Available
Mercy Cancer Center at Mercy Medical Center
Cleveland, Ohio 44708
United StatesSite Not Available
Southwest General Health Center
Cleveland, Ohio 44130
United StatesSite Not Available
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio 44708
United StatesSite Not Available
UHHS Westlake Medical Center
Cleveland, Ohio 44145
United StatesSite Not Available
University Suburban Health Center
Cleveland, Ohio 44143
United StatesSite Not Available
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