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

NCT00245050 | Completed Phase 3 Results DMC

• 2 other identifiers: CASE5Y03P30CA043703
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 8

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G)

  After Cycle 3 of chemotherapy (on average at 3 months)

Study Arms (2)

Pyridoxine

EXPERIMENTAL

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; Drug: doxorubicin HCL liposome

Placebo

PLACEBO COMPARATOR

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; Drug: doxorubicin HCL liposome

Interventions

pyridoxine hydrochloride 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.

Pyridoxine

Placebo 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.

Placebo

doxorubicin HCL liposome DRUG

IV, 40mg/m2

Placebo; Pyridoxine

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

Geauga Regional Hospital

Cleveland, Ohio, 44024, United States

Location

Lake/University Ireland Cancer Center

Cleveland, Ohio, 44060, United States

Location

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

Cleveland, Ohio, 44106-5065, United States

Location

Southwest General Health Center

Cleveland, Ohio, 44130, United States

Location

University Suburban Health Center

Cleveland, Ohio, 44143, United States

Location

UHHS Westlake Medical Center

Cleveland, Ohio, 44145, United States

Location

Mercy Cancer Center at Mercy Medical Center

Cleveland, Ohio, 44708, United States

Location

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, 44708, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Drug-Related Side Effects and Adverse Reactions; Endometrial Neoplasms; Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Breast Neoplasms, Male

Interventions

Pyridoxine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Chemically-Induced Disorders; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fallopian Tube Diseases; Adnexal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Interim analysis was conducted after 30 patients were enrolled and had evaluable PPE assessment data. Due to decreased accrual and similar PPE rates between groups, the trial was closed for enrollment after the interim analyses was completed.

Results Point of Contact

• Title: Vivian von Gruenigen, MD
• Organization: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

vev1@case.edu

216-844-5011

Study Officials

• Vivian von Gruenigen, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: April 1, 2004
• Primary Completion: April 1, 2008
• Study Completion: September 1, 2011
• Last Updated: December 30, 2011
• Results First Posted: December 22, 2010

Record last verified: 2011-12

Locations

US (8)