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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00245050
First received: October 25, 2005
Last updated: December 28, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug/Agent Toxicity by Tissue/Organ
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Dietary Supplement: pyridoxine hydrochloride
Drug: Placebo
Drug: doxorubicin HCL liposome
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Double-Blind Randomized Trial of Pyridoxine Versus Placebo for the Prevention of Doxil-Related Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) [ Time Frame: Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G) [ Time Frame: After Cycle 3 of chemotherapy (on average at 3 months) ] [ Designated as safety issue: No ]
    QOL was measured with the FACT-G questionnaire following the third course of doxorubicin HCl liposome before the patient was seen by the treating physician and before chemotherapy was administered. The FACT-G, version 4, is a 27-item core questionnaire evaluating the domains of physical, functional, family-social, and emotional well-being (PWB, FWB, SWB, EWB). Total score ranges from 0-108 and higher scores indicate better QOL.


Enrollment: 34
Study Start Date: April 2004
Study Completion Date: September 2011
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Dietary Supplement: 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.
Drug: doxorubicin HCL liposome
IV, 40mg/m2
Placebo Comparator: 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.
Drug: 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.
Drug: doxorubicin HCL liposome
IV, 40mg/m2

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245050

Locations
United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Geauga Regional Hospital
Cleveland, Ohio, United States, 44024
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States, 44060
Mercy Cancer Center at Mercy Medical Center
Cleveland, Ohio, United States, 44708
Southwest General Health Center
Cleveland, Ohio, United States, 44130
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44708
UHHS Westlake Medical Center
Cleveland, Ohio, United States, 44145
University Suburban Health Center
Cleveland, Ohio, United States, 44143
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Vivian von Gruenigen, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00245050     History of Changes
Other Study ID Numbers: CASE5Y03, P30CA043703, CASE5Y03
Study First Received: October 25, 2005
Results First Received: October 26, 2010
Last Updated: December 28, 2011
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Fallopian Tube Neoplasms
Hand-Foot Syndrome
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Breast Diseases
Chemically-Induced Disorders
Dermatitis
Digestive System Diseases
Digestive System Neoplasms
Drug Eruptions
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Skin Diseases
Urogenital Neoplasms
Doxorubicin
Liposomal doxorubicin
Pyridoxal

ClinicalTrials.gov processed this record on October 22, 2014