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

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ClinicalTrials.gov Identifier: NCT00245050
Recruitment Status : Completed
First Posted : October 27, 2005
Results First Posted : December 22, 2010
Last Update Posted : December 30, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Breast Cancer
Drug/Agent Toxicity by Tissue/Organ
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Interventions Dietary Supplement: pyridoxine hydrochloride
Drug: Placebo
Drug: doxorubicin HCL liposome
Enrollment 34
Recruitment Details Patients were recruited from the outpatient gynecologic oncology clinics at University Hospitals from May 2004 to December 2007.
Pre-assignment Details 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.
Arm/Group Title Pyridoxine Placebo
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 18 16
Completed 15 14
Not Completed 3 2
Reason Not Completed
Adverse Event             3             2
Arm/Group Title Pyridoxine Placebo Total
Hide Arm/Group Description 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 of all reporting groups
Overall Number of Baseline Participants 18 16 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  44.4%
6
  37.5%
14
  41.2%
>=65 years
10
  55.6%
10
  62.5%
20
  58.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 16 participants 34 participants
62.9  (9.4) 65.9  (11.0) 64.3  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 16 participants 34 participants
Female
18
 100.0%
16
 100.0%
34
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 16 participants 34 participants
18 16 34
1.Primary Outcome
Title Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)
Hide Description 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.
Time Frame Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Pyridoxine Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15 14
Measure Type: Number
Unit of Measure: participants
Grade 1 HFS 2 3
Grade 2 HFS 3 3
Grade 3 HFS 3 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pyridoxine, Placebo
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.536 to 2.16
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G)
Hide Description 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.
Time Frame After Cycle 3 of chemotherapy (on average at 3 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pyridoxine Placebo
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 15 14
Mean (Standard Deviation)
Unit of Measure: Total scores on FACT-G scale
84.9  (10.2) 84.4  (9.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pyridoxine, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.916
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 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
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pyridoxine Placebo
Hide Arm/Group Description 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.
All-Cause Mortality
Pyridoxine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pyridoxine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/15 (53.33%)      6/14 (42.86%)    
Blood and lymphatic system disorders     
Blood/bone marrow   1/15 (6.67%)  4 2/14 (14.29%)  4
Hemorrhage/bleeding   1/15 (6.67%)  1 0/14 (0.00%)  0
Lymphatics   0/15 (0.00%)  0 0/14 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal   2/15 (13.33%)  2 0/14 (0.00%)  0
General disorders     
Constitutional symptoms   0/15 (0.00%)  0 1/14 (7.14%)  1
Pain   0/15 (0.00%)  0 0/14 (0.00%)  0
Immune system disorders     
Allergy/immunologic   0/15 (0.00%)  0 1/14 (7.14%)  1
Infections and infestations     
Infection   1/15 (6.67%)  1 0/14 (0.00%)  0
Metabolism and nutrition disorders     
Metabolic/laboratory   0/15 (0.00%)  0 1/14 (7.14%)  1
Nervous system disorders     
Neurology   1/15 (6.67%)  1 0/14 (0.00%)  0
Renal and urinary disorders     
Renal/genitourinary   0/15 (0.00%)  0 0/14 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pulmonary/upper respiratory   1/15 (6.67%)  1 0/14 (0.00%)  0
Vascular disorders     
Vascular   1/15 (6.67%)  1 1/14 (7.14%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pyridoxine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/15 (86.67%)      10/14 (71.43%)    
Blood and lymphatic system disorders     
Blood/bone marrow   7/15 (46.67%)  36 8/14 (57.14%)  42
Lymphatics   2/15 (13.33%)  2 2/14 (14.29%)  2
Gastrointestinal disorders     
Gastrointestinal   9/15 (60.00%)  11 5/14 (35.71%)  7
General disorders     
Constitutional symptoms   7/15 (46.67%)  7 5/14 (35.71%)  8
Pain   5/15 (33.33%)  5 2/14 (14.29%)  6
Hepatobiliary disorders     
Hepatic/pancreas   0/15 (0.00%)  0 2/14 (14.29%)  2
Infections and infestations     
Infection   2/15 (13.33%)  2 1/14 (7.14%)  3
Metabolism and nutrition disorders     
Metabolic/laboratory   1/15 (6.67%)  3 1/14 (7.14%)  6
Musculoskeletal and connective tissue disorders     
Musculoskeletal/soft tissue   0/15 (0.00%)  0 2/14 (14.29%)  2
Nervous system disorders     
Neurology   3/15 (20.00%)  3 1/14 (7.14%)  1
Renal and urinary disorders     
Renal/genitourinary   2/15 (13.33%)  3 3/14 (21.43%)  3
Respiratory, thoracic and mediastinal disorders     
Pulmonary/upper respiratory   2/15 (13.33%)  2 4/14 (28.57%)  5
Indicates events were collected by systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Vivian von Gruenigen, MD
Organization: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Phone: 216-844-5011
EMail: vev1@case.edu
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00245050     History of Changes
Other Study ID Numbers: CASE5Y03
P30CA043703 ( U.S. NIH Grant/Contract )
CASE5Y03 ( Other Identifier: Case Comprehensive Cancer Center )
First Submitted: October 25, 2005
First Posted: October 27, 2005
Results First Submitted: October 26, 2010
Results First Posted: December 22, 2010
Last Update Posted: December 30, 2011