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

Primary Purpose

Breast Cancer, Drug/Agent Toxicity by Tissue/Organ, Endometrial Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
pyridoxine hydrochloride
Placebo
doxorubicin HCL liposome
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Geauga Regional Hospital
  • Lake/University Ireland Cancer Center
  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
  • Southwest General Health Center
  • University Suburban Health Center
  • UHHS Westlake Medical Center
  • Mercy Cancer Center at Mercy Medical Center
  • UHHS Chagrin Highlands Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Pyridoxine

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)
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)
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.

Full Information

First Posted
October 25, 2005
Last Updated
December 28, 2011
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00245050
Brief Title
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer
Official Title
A Double-Blind Randomized Trial of Pyridoxine Versus Placebo for the Prevention of Doxil-Related Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Drug/Agent Toxicity by Tissue/Organ, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pyridoxine
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
pyridoxine hydrochloride
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Intervention Name(s)
doxorubicin HCL liposome
Intervention Description
IV, 40mg/m2
Primary Outcome Measure Information:
Title
Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)
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.
Time Frame
Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.
Secondary Outcome Measure Information:
Title
Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G)
Description
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.
Time Frame
After Cycle 3 of chemotherapy (on average at 3 months)

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian von Gruenigen, MD
Organizational Affiliation
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geauga Regional Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44024
Country
United States
Facility Name
Lake/University Ireland Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5065
Country
United States
Facility Name
Southwest General Health Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
University Suburban Health Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44143
Country
United States
Facility Name
UHHS Westlake Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Mercy Cancer Center at Mercy Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Facility Name
UHHS Chagrin Highlands Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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