Status:
COMPLETED
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Drug/Agent Toxicity by Tissue/Organ
Eligibility:
FEMALE
Phase:
PHASE3
Brief 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 synd...
Detailed 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, fallop...
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
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00245050
Start Date
April 1 2004
End Date
September 1 2011
Last Update
December 30 2011
Active Locations (8)
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1
Geauga Regional Hospital
Cleveland, Ohio, United States, 44024
2
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States, 44060
3
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
4
Southwest General Health Center
Cleveland, Ohio, United States, 44130