Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2011-09-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Drug/Agent Toxicity by Tissue/Organ Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pyridoxine

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.

Group Type EXPERIMENTAL

pyridoxine hydrochloride

Intervention Type DIETARY_SUPPLEMENT

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.

doxorubicin HCL liposome

Intervention Type DRUG

IV, 40mg/m2

Placebo

Arm II: Patients receive doxorubicin HCl liposome IV 40 mg/m2 over 1 hour on day 1 and oral placebo twice 100 mg daily on days 1-28.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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.

doxorubicin HCL liposome

Intervention Type DRUG

IV, 40mg/m2

Interventions

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pyridoxine hydrochloride

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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.

Intervention Type DRUG

doxorubicin HCL liposome

IV, 40mg/m2

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vivian von Gruenigen, MD

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

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