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Pyridoxine

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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 40 mg/m2 over 1 hour on day 1 and oral pyridoxine twice 100 mg daily on days 1-28.

pyridoxine hydrochloride

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

Vivian von Gruenigen, MD

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.

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.

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)

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.

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.

National Cancer Institute (NCI)

Case Comprehensive Cancer Center

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.

Total

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

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.

Based on published literature, it is estimated that the incidence of HFS for all grades is 49%. A decrease of 50% or more in the incidence of HFS in patients receiving pyridoxine would be of clinical significance. A sample size of 27 patients per group was chosen as this would allow us to detect a difference between HFS incidence of 49% and 11.5% (alpha=0.05, two-sided, power=0.80). Interim analysis was conducted after 30 patients were enrolled and had evaluable HFS assessment data.

Grade 1 HFS

Grade 2 HFS

Grade 3 HFS

Patients were evaluable for PPE/HFS(Hand-Foot Syndrome) incidence and toxicity assessment if they received at least one course of chemotherapy. Intention to treat analysis was used.

Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)

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

Overall Study

Capecitabine

Pyridoxine (200mg) or placebo once daily orally for 21 days out of each treatment cycle

Yoon-Sim Yap, FRACP, MBBS

RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients with cancer. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome in patients with cancer.

PURPOSE: This randomized phase III trial is studying pyridoxine to see how well it works compared with a placebo in preventing hand-foot syndrome caused by capecitabine in patients with cancer.

OBJECTIVES:

Primary

* Compare the incidence of capecitabine-induced palmar-plantar erythrodysesthesia (hand-foot syndrome \[HFS\]) ≥ grade 2 in patients with cancer treated with pyridoxine hydrochloride vs placebo.

Secondary

* Compare the time to onset of HFS ≥ grade 2 in patients treated with these regimens.
* Compare the quality of life changes in patients treated with these regimens.
* Identify factors predicting toxicity from capecitabine chemotherapy.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender and treatment setting (adjuvant/neoadjuvant vs palliative setting). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Beginning concurrently with planned capecitabine treatment, patients receive oral pyridoxine hydrochloride once daily on days 1-21.
* Arm II: Beginning concurrently with planned capecitabine treatment, patients receive oral placebo once daily on days 1-21.

In both arms, treatment repeats every 21 days for up to 8 courses (until discontinuation of capecitabine treatment).

Quality of life is assessed at baseline, at the beginning of courses 2, 4, 6, and 8, and at the end of the study.

Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer

Randomized Double-Blind Placebo-Controlled Trial of Pyridoxine for Prevention of Capecitabine-Induced Hand-Foot Syndrome (HFS)

National Cancer Centre, Singapore

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer	NCT00245050	Breast Cancer Drug/Agent Toxi... Endometrial Can... Fallopian Tube ... Ovarian Cancer Peritoneal Cavi...	pyridoxine hydr... Placebo doxorubicin HCL...	-	Case Comprehensive Cancer Center
Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer	NCT00486213	Dermatologic Co... Palmar-plantar ... Unspecified Adu...	pyridoxine hydr... Placebo	18 Years -	National Cancer Centre, Singapore
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer	NCT00245050	Breast Cancer Drug/Agent Toxi... Endometrial Can... Fallopian Tube ... Ovarian Cancer Peritoneal Cavi...	pyridoxine hydr... Placebo doxorubicin HCL...	-	Case Comprehensive Cancer Center

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