Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer
This study has been completed.
Sponsor:
Case Comprehensive Cancer Center
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
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Pyridoxine hydrochloride
Pyridoxine
Doxorubicin
Doxorubicin hydrochloride
U.S. FDA Resources
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
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 Endometrial Neoplasms Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Adenoma Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Diseases Genital Diseases, Female |
Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Doxorubicin Pyridoxine Vitamin B 6 |
ClinicalTrials.gov processed this record on May 23, 2013