A Double-Blind Randomized Trial of Pyridoxine Versus Placebo for the Prevention of Doxil-Related Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)
Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific doxorubicin HCl liposome related toxicities using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 3.0.
Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.
Vivian von Gruenigen, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Mercy Cancer Center at Mercy Medical Center||Canton, Ohio 44708|
|Lake/University Ireland Cancer Center||Mentor, Ohio 44060|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|
|Geauga Regional Hospital||Chardon, Ohio 44024|
|Southwest General Health Center||Middleburgh Heights, Ohio 44130|
|UHHS Chagrin Highlands Medical Center||Orange Villager, Ohio 44122|
|University Suburban Health Center||South Euclid, Ohio 44121|
|UHHS Westlake Medical Center||Westlaker, Ohio 44145|