Phase 3
N=34
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 · Fallopian Tube Cancer · Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00245050 ↗Enrolled (actual)
34
Serious AEs
48.3%
Results posted
Dec 2010
Primary outcome: Primary: Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) — 2; 3; 3; 3 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- pyridoxine hydrochloride (Dietary_supplement); Placebo (Drug); doxorubicin HCL liposome (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Case Comprehensive Cancer Center
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) |
2; 3; 3; 3; 3; 1 | <0.05 sig |
| SECONDARY Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G) |
84.9; 84.4 | 0.916 |
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.
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
Data sourced from ClinicalTrials.gov (NCT00245050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.