Breast Cancer

Colorectal Cancer

Palmar-plantar Erythrodysesthesia

pyridoxine hydrochloride

placebo

quality-of-life assessment

Basildon University Hospital

Primrose Oncology Unit

West Suffolk Hospital

Addenbrooke's Hospital

Kent and Canterbury Hospital

Derbyshire Royal Infirmary

Royal Devon and Exeter Hospital

Queen Elizabeth Hospital

Royal Albert Edward Infirmary

Mid Kent Oncology Centre at Maidstone Hospital

Peterborough Hospitals Trust

Derriford Hospital

Great Western Hospital

Kent and Sussex Hospital

Walsall Manor Hospital

Southend University Hospital NHS Foundation Trust

Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer

A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome

Cambridge University Hospitals NHS Foundation Trust

Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21.

Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.

Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I (closed to accrual as of 10/24/2007).

Patients receive placebo cream as in arm III and oral placebo as in arm II (closed to accrual as of 10/24/2007).

Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21.

Patients receive placebo cream applied to palms and soles twice daily on days 1-21.

Urea/Lactic Acid Cream

Placebo Cream

Total

Age, Customized

Sex: Female, Male

Region of Enrollment

A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms in either hands or feet were tabulated and percentages are reported.

Patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily.

Patients receive placebo cream applied to palms and soles twice daily.

To Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream Can Decrease the Incidence/Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia

Frequency and severity of adverse events reported by patients in weekly diary and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.

To Evaluate the Potential Toxicity of Urea/Lactic Acid Cream

A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated and percentages are reported.

Arm I: (Urea/Lactic Acid +Vit B6)

Arm II: (Urea/Lactic Acid + Placebo)

Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in Arm I

Arm III: (Placebo +Vit B6)

Patients receive placebo cream and oral placebo.

Arm IV: (Placebo + Placebo)

Arm V: Urea/Lactic Acid

Arm VI: (Placebo)

Determine Whether the Prophylactic Use of Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine-caused Palmar-plantar Erythrodysesthesia (HFSD).

Patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm I.

Patients receive placebo cream as in arm III and oral placebo as in arm II.

Evaluate the Potential Toxicity of Vitamin B6.

A patient self-reported hand-foot syndrome diary (HFSD) was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms were tabulated.

Patients receive topical urea/lactic acid-based cream as in arm I (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21.
urea/lactic acid-based topical cream: Applied topically
placebo: Given orally or applied topically

Determine Whether the Prophylactic Use of a Topical Urea/Lactic Acid Cream in Combination With Vitamin B6 Can Decrease the Incidence and/or Severity of Capecitabine Caused Palmar-plantar Erythrodysesthesia.

Overall Study

Charles Lawrence Loprinzi, M.D.

Drug/Agent Toxicity by Tissue/Organ

Unspecified Adult Solid Tumor, Protocol Specific

urea/lactic acid-based topical cream

Mayo Clinic Scottsdale

Aurora Presbyterian Hospital

Boulder Community Hospital

Penrose Cancer Center at Penrose Hospital

St. Anthony Central Hospital

Porter Adventist Hospital

Presbyterian - St. Luke's Medical Center

St. Joseph Hospital

Rose Medical Center

CCOP - Colorado Cancer Research Program

Swedish Medical Center

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

North Colorado Medical Center

Sky Ridge Medical Center

Hope Cancer Care Center at Longmont United Hospital

McKee Medical Center

St. Mary - Corwin Regional Medical Center

North Suburban Medical Center

Exempla Lutheran Medical Center

Memorial Cancer Institute at Memorial Regional Hospital

Mayo Clinic - Jacksonville

Rush-Copley Cancer Care Center

St. Joseph Medical Center

Graham Hospital

Memorial Hospital

Eureka Community Hospital

Galesburg Clinic, PC

Galesburg Cottage Hospital

Mason District Hospital

Hopedale Medical Complex

Joliet Oncology-Hematology Associates, Limited - West

McDonough District Hospital

Trinity Cancer Center at Trinity Medical Center - 7th Street Campus

BroMenn Regional Medical Center

Community Cancer Center

Community Hospital of Ottawa

Oncology Hematology Associates of Central Illinois, PC - Ottawa

Cancer Treatment Center at Pekin Hospital

Proctor Hospital

CCOP - Illinois Oncology Research Association

Oncology Hematology Associates of Central Illinois, PC - Peoria

Methodist Medical Center of Illinois

OSF St. Francis Medical Center

Illinois Valley Community Hospital

Perry Memorial Hospital

St. Margaret's Hospital

Carle Cancer Center at Carle Foundation Hospital

CCOP - Carle Cancer Center

St. Francis Hospital and Health Centers - Beech Grove Campus

Elkhart General Hospital

Howard Community Hospital

Saint Anthony Memorial Health Centers

Reid Hospital & Health Care Services

CCOP - Northern Indiana CR Consortium

Memorial Hospital of South Bend

Saint Joseph Regional Medical Center

South Bend Clinic

McFarland Clinic, PC

Cedar Rapids Oncology Associates

Mercy Regional Cancer Center at Mercy Medical Center

Mercy Capitol Hospital

CCOP - Iowa Oncology Research Association

John Stoddard Cancer Center at Iowa Methodist Medical Center

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

Medical Oncology and Hematology Associates at Mercy Cancer Center

Mercy Cancer Center at Mercy Medical Center - Des Moines

John Stoddard Cancer Center at Iowa Lutheran Hospital

McCreery Cancer Center at Ottumwa Regional

Siouxland Hematology-Oncology Associates, LLP

Mercy Medical Center - Sioux City

St. Luke's Regional Medical Center

Cancer Center of Kansas, PA - Chanute

Cancer Center of Kansas, PA - Dodge City

Cancer Center of Kansas, PA - El Dorado

Cancer Center of Kansas-Independence

Cancer Center of Kansas, PA - Kingman

Southwest Medical Center

Cancer Center of Kansas, PA - Newton

Cancer Center of Kansas, PA - Parsons

Cancer Center of Kansas, PA - Pratt

Cancer Center of Kansas, PA - Salina

Cancer Center of Kansas, PA - Wellington

Associates in Womens Health, PA - North Review

Cancer Center of Kansas, PA - Medical Arts Tower

Cancer Center of Kansas, PA - Wichita

CCOP - Wichita

Via Christi Cancer Center at Via Christi Regional Medical Center

Cancer Center of Kansas, PA - Winfield

Hickman Cancer Center at Bixby Medical Center

Saint Joseph Mercy Cancer Center

CCOP - Michigan Cancer Research Consortium

Oakwood Cancer Center at Oakwood Hospital and Medical Center

Green Bay Oncology, Limited - Escanaba

Genesys Hurley Cancer Institute

Hurley Medical Center

Van Elslander Cancer Center at St. John Hospital and Medical Center

Dickinson County Healthcare System

Foote Memorial Hospital

Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer

A Phase III Randomized, Placebo-controlled, Double-blind Trial to Determine the Effectiveness of a Urea/Lactic Acid-Based Topical Keratolytic Agent and Vitamin B-6 for Prevention of Capecitabine-Induced Hand and Foot Syndrome

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

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.

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.

Pyridoxine

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.

Placebo

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.

Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)

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.

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

Vivian von Gruenigen, MD

Endometrial Cancer

Fallopian Tube Cancer

Ovarian Cancer

Peritoneal Cavity Cancer

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.

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.

doxorubicin HCL liposome

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

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

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

Case Comprehensive Cancer Center

Metastatic Breast Cancer

Doxil and Vinorelbine

Hematology Oncology Consultants, Inc

A Trial of Doxil and Multiday Vinorelbine in Patients With Metastatic Breast Cancer

A Phase II Trial of Doxil and Multiday Vinorelbine in Patients With Metastatic Breast Cancer

Hematology Oncology Consultants

pyridoxine/rak dojke

Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer

Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer

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

A Trial of Doxil and Multiday Vinorelbine in Patients With Metastatic Breast Cancer

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