Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer
Condition: Breast Cancer; Drug/Agent Toxicity by Tissue/Organ; Endometrial Cancer; Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Breast Neoplasms; Endometrial Neoplasms; Fallopian Tube Neoplasms; Hand-Foot Syndrome; Drug-Related Side Effects and Adverse Reactions
Intervention: pyridoxine hydrochloride; Placebo; doxorubicin HCL liposome
Intervention description: Arm I: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral pyridoxine twice 100 mg daily on days 1-28.; Arm II: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.; IV, 40mg/m2
Intervention MeSH terms: Pyridoxine; Vitamin B 6; Doxorubicin; Liposomal doxorubicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 34.0
Sex: Female
Healthy volunteers: No
Keywords: drug/agent toxicity by tissue/organ; fallopian tube cancer; peritoneal cavity cancer; recurrent ovarian epithelial cancer; recurrent endometrial carcinoma; stage III endometrial carcinoma; stage IV endometrial carcinoma; stage IV breast cancer; male breast cancer; recurrent breast 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.
    

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