Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer
Breast Cancer, Drug/Agent Toxicity by Tissue/Organ, Endometrial Cancer
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring drug/agent toxicity by tissue/organ, fallopian tube cancer, peritoneal cavity cancer, recurrent ovarian epithelial cancer, recurrent endometrial carcinoma, stage III endometrial carcinoma, stage IV endometrial carcinoma, stage IV breast cancer, male breast cancer, recurrent breast cancer
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
Sites / Locations
- Geauga Regional Hospital
- Lake/University Ireland Cancer Center
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
- Southwest General Health Center
- University Suburban Health Center
- UHHS Westlake Medical Center
- Mercy Cancer Center at Mercy Medical Center
- UHHS Chagrin Highlands Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Pyridoxine
Placebo
Arm I: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
Arm II: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral placebo twice 100 mg daily on days 1-28.