Breast CancerPhase 3NCT00245050
Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Liposomal Doxorubicin for Cancer
A Phase 3 study testing pyridoxine hydrochloride and doxorubicin HCL liposome in people with Breast Cancer and Drug/Agent Toxicity by Tissue/Organ, run by Case Comprehensive Cancer Center at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, Drug/Agent Toxicity by Tissue/Organ, Endometrial Cancer
- What is being tested?
- pyridoxine hydrochloride and doxorubicin HCL liposome
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2004to Sep 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Geauga Regional Hospital
Cleveland, Ohio, 44024
Lake/University Ireland Cancer Center
Cleveland, Ohio, 44060
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Southwest General Health Center
Cleveland, Ohio, 44130
University Suburban Health Center
Cleveland, Ohio, 44143
UHHS Westlake Medical Center
Cleveland, Ohio, 44145
Mercy Cancer Center at Mercy Medical Center
Cleveland, Ohio, 44708
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, 44708
About this study
Official title: A Double-Blind Randomized Trial of Pyridoxine Versus Placebo for the Prevention of Doxil-Related Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Drug/Agent Toxicity by Tissue/Organ, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
- Being tested
- pyridoxine hydrochloride, Placebo, doxorubicin HCL liposome
- 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
- Medical subject headings
- Breast Neoplasms, Drug-Related Side Effects and Adverse Reactions, Endometrial Neoplasms, Fallopian Tube Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyridoxine hydrochlorideDietary 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.
PlaceboDrug
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 liposomeDrug
IV, 40mg/m2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo; Drug: doxorubicin HCL liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: After Cycle 3 of chemotherapy (on average at 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startApr 2004
- Primary completionApr 2008
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vivian von Gruenigen, MD, Principal investigator, Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245050
- Sponsor's protocol ID
- CASE5Y03
- Other IDs
- P30CA043703, CASE5Y03
- Status last verified
- Dec 2011
- First submitted
- 25 Oct 2005
- Last updated
- 30 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomized Trial of Pyridoxine Versus Placebo for the Prevention of Doxil-Related Palmar-Plantar Erythrodysesthesia (Hand-Foot Syndrome)
- ClinicalTrials.gov ID
- NCT00245050
- Acronym / sponsor ID
- CASE5Y03
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2004
- Primary completion
- Apr 2008 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Oct 2005 (estimated)
- Results
- Posted 22 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyridoxine | Experimental | Dietary Supplement: pyridoxine hydrochloride, Drug: doxorubicin HCL liposomeArm 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. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: doxorubicin HCL liposomeArm 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pyridoxine hydrochlorideArm 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. | Dietary supplement | Pyridoxine |
| PlaceboArm 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. | Drug | Placebo |
| doxorubicin HCL liposomeIV, 40mg/m2 | Drug | Placebo, Pyridoxine |
Primary outcome
Number of Participants With Palmar-plantar Erythrodysesthesia (PPE)
Time frame: Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.
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.
1 secondary outcome
Quality of Life (QOL) as Measured by Functional Assessment of Cancer Therapy (FACT-G)
Time frame: After Cycle 3 of chemotherapy (on average at 3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivian von Gruenigen, MD principal investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pyridoxine hydrochloride and doxorubicin HCL liposome in people with Breast Cancer and Drug/Agent Toxicity by Tissue/Organ, run by Case Comprehensive Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Palmar-plantar Erythrodysesthesia (PPE) (time frame: Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2011.