Brief Title
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer
Official Title
A Double-Blind Randomized Trial of Pyridoxine Versus Placebo for the Prevention of Doxil-Related Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)
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 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.
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, 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)
Secondary Outcome
Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G)
Condition
Breast Cancer
Intervention
pyridoxine hydrochloride
Study Arms / Comparison Groups
Pyridoxine
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
34
Start Date
April 2004
Completion Date
September 2011
Primary Completion Date
April 2008
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
Gender
Female
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Vivian von Gruenigen, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00245050
Organization ID
CASE5Y03
Secondary IDs
P30CA043703
Responsible Party
Sponsor
Study Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Vivian von Gruenigen, MD, Principal Investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Verification Date
December 2011