Breast Cancer Clinical Trial
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer
Summary
RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome.
PURPOSE: This randomized clinical trial is studying pyridoxine to see how well it works compared to a placebo in preventing hand-foot syndrome in patients who are receiving liposomal doxorubicin for recurrent ovarian, fallopian tube, or peritoneal cancer, metastatic breast cancer, or advanced endometrial cancer.
Full Description
OBJECTIVES:
Primary
Compare the efficacy of pyridoxine vs placebo in preventing palmar-plantar erythrodysesthesia (PPE) in patients receiving doxorubicin HCl liposome for recurrent ovarian, fallopian tube, or peritoneal cavity cancer, metastatic breast cancer, or advanced endometrial cancer.
Compare quality of life in patients treated with these regimens.
OUTLINE: This is a randomized, double-blind study. Patients are stratified according to cancer type (ovarian, fallopian tube, or peritoneal cavity cancer vs breast cancer vs endometrial cancer). Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive doxorubicin HCl liposome IV 40mg/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 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
In both arms, treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients who develop grade 2-3 palmar-plantar erythrodysesthesia despite dose reduction of doxorubicin HCl liposome are unblinded and removed from the study (for patients in arm I) OR receive oral pyridoxine twice daily beginning day 1 of the next planned therapy (for patients in arm II).
Quality of life is assessed at baseline and after every third course of therapy.
After completion of study treatment, patients are followed periodically for 6 months.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
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
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There are 7 Locations for this study
Cleveland Ohio, 44024, United States
Cleveland Ohio, 44060, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44130, United States
Cleveland Ohio, 44143, United States
Cleveland Ohio, 44145, United States
Cleveland Ohio, 44708, United States
Cleveland Ohio, 44708, United States
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