Trial Outcomes & Findings for Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer (NCT NCT00245050)

Last Updated: 2011-12-30

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

34 participants

Primary outcome timeframe

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

Results posted on

2011-12-30

Participant Flow

Patients were recruited from the outpatient gynecologic oncology clinics at University Hospitals from May 2004 to December 2007.

Patients were required to have discontinued corticosteroid therapy at least three weeks prior to enrollment and no corticosteroids were allowed for the duration of the trial. Patients must have discontinued pyridoxine therapy at least three weeks prior to enrollment.

Participant milestones

Participant milestones
Measure	Pyridoxine 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.	Placebo 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.
Overall Study STARTED	18	16
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Pyridoxine 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.	Placebo 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.
Overall Study Adverse Event	3	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pyridoxine n=18 Participants 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.	Placebo n=16 Participants 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 n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age Continuous	62.9 years STANDARD_DEVIATION 9.4 • n=5 Participants	65.9 years STANDARD_DEVIATION 11.0 • n=7 Participants	64.3 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	16 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

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

Population: 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.

Outcome measures

Outcome measures
Measure	Pyridoxine n=15 Participants 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.	Placebo n=14 Participants 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.
Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 1 HFS	2 participants	3 participants
Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 2 HFS	3 participants	3 participants
Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) Grade 3 HFS	3 participants	1 participants

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Pyridoxine n=15 Participants 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.	Placebo n=14 Participants 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.
Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G)	84.9 Total scores on FACT-G scale Standard Deviation 10.2	84.4 Total scores on FACT-G scale Standard Deviation 9.5

Adverse Events

Pyridoxine

Serious events: 8 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pyridoxine n=15 participants at risk 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.	Placebo n=14 participants at risk 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.
Immune system disorders Allergy/immunologic	0.00% 0/15 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	7.1% 1/14 • Number of events 1 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Blood and lymphatic system disorders Blood/bone marrow	6.7% 1/15 • Number of events 4 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	14.3% 2/14 • Number of events 4 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
General disorders Constitutional symptoms	0.00% 0/15 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	7.1% 1/14 • Number of events 1 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Gastrointestinal disorders Gastrointestinal	13.3% 2/15 • Number of events 2 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	0.00% 0/14 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Blood and lymphatic system disorders Hemorrhage/bleeding	6.7% 1/15 • Number of events 1 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	0.00% 0/14 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Infections and infestations Infection	6.7% 1/15 • Number of events 1 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	0.00% 0/14 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Blood and lymphatic system disorders Lymphatics	0.00% 0/15 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	0.00% 0/14 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Metabolism and nutrition disorders Metabolic/laboratory	0.00% 0/15 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	7.1% 1/14 • Number of events 1 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Nervous system disorders Neurology	6.7% 1/15 • Number of events 1 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	0.00% 0/14 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
General disorders Pain	0.00% 0/15 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	0.00% 0/14 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory	6.7% 1/15 • Number of events 1 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	0.00% 0/14 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Renal and urinary disorders Renal/genitourinary	0.00% 0/15 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	0.00% 0/14 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Vascular disorders Vascular	6.7% 1/15 • Number of events 1 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	7.1% 1/14 • Number of events 1 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0

Other adverse events

Other adverse events
Measure	Pyridoxine n=15 participants at risk 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.	Placebo n=14 participants at risk 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.
Blood and lymphatic system disorders Blood/bone marrow	46.7% 7/15 • Number of events 36 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	57.1% 8/14 • Number of events 42 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
General disorders Constitutional symptoms	46.7% 7/15 • Number of events 7 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	35.7% 5/14 • Number of events 8 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Gastrointestinal disorders Gastrointestinal	60.0% 9/15 • Number of events 11 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	35.7% 5/14 • Number of events 7 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Hepatobiliary disorders Hepatic/pancreas	0.00% 0/15 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	14.3% 2/14 • Number of events 2 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Infections and infestations Infection	13.3% 2/15 • Number of events 2 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	7.1% 1/14 • Number of events 3 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Blood and lymphatic system disorders Lymphatics	13.3% 2/15 • Number of events 2 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	14.3% 2/14 • Number of events 2 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Metabolism and nutrition disorders Metabolic/laboratory	6.7% 1/15 • Number of events 3 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	7.1% 1/14 • Number of events 6 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue	0.00% 0/15 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	14.3% 2/14 • Number of events 2 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Nervous system disorders Neurology	20.0% 3/15 • Number of events 3 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	7.1% 1/14 • Number of events 1 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
General disorders Pain	33.3% 5/15 • Number of events 5 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	14.3% 2/14 • Number of events 6 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Respiratory, thoracic and mediastinal disorders Pulmonary/upper respiratory	13.3% 2/15 • Number of events 2 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	28.6% 4/14 • Number of events 5 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0
Renal and urinary disorders Renal/genitourinary	13.3% 2/15 • Number of events 3 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0	21.4% 3/14 • Number of events 3 • Patients were monitored weekly with phone calls from the research nurse and monthly at clinic visits for overall (including pyridoxine) and specific PLD-related toxicities using the NCI CTCAE, version 3.0

Additional Information

Vivian von Gruenigen, MD

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

Phone: 216-844-5011

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place