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A Double-Blind Randomized Trial of Pyridoxine Versus Placebo for the Prevention of Doxil-Related Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)


Phase 3
N/A
N/A
Not Enrolling
Female
Breast Cancer, Drug/Agent Toxicity by Tissue/Organ, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

A Double-Blind Randomized Trial of Pyridoxine Versus Placebo for the Prevention of Doxil-Related Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)

Outcome Description:

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.

Outcome Time Frame:

Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.

Safety Issue:

Yes

Principal Investigator

Vivian von Gruenigen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CASE5Y03

NCT ID:

NCT00245050

Start Date:

April 2004

Completion Date:

September 2011

Related Keywords:

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

Name

Location

Mercy Cancer Center at Mercy Medical CenterCanton, Ohio  44708
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Geauga Regional HospitalChardon, Ohio  44024
Southwest General Health CenterMiddleburgh Heights, Ohio  44130
UHHS Chagrin Highlands Medical CenterOrange Villager, Ohio  44122
University Suburban Health CenterSouth Euclid, Ohio  44121
UHHS Westlake Medical CenterWestlaker, Ohio  44145