CancerPhase 3NCT00082433

Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

A Phase 3 study testing Ixabepilone + Capecitabine and Capecitabine in people with Cancer and Breast Cancer, run by R-Pharm at 186 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Cancer, Breast Cancer
What is being tested?: Ixabepilone + Capecitabine and Capecitabine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,221 participants
Where: 186 sitesin 29 countries
Study dates: Nov 2003to Mar 2008
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Patients must have received prior treatment which included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
Patients must have received no more than two prior chemotherapy regimens. Patients who have not received treatment for metastatic disease must have relapsed within one year.
Patients may not have any history of brain and/or leptomeningeal metastases.
Patients may not have Grade 2 or worse neuropathy at the time of study entry.
Patients may not have had prior treatment with any epothilones and/or capecitabine (i.e. Xeloda)

Trial locations and contacts

186 sites in 29 countries.

Country

City, postcode or hospital

186 sites in 29 countries

United States34 sites

Local Institution
Albuquerque, New Mexico
Local Institution
Baton Rouge, Louisiana
Local Institution
Bethesda, Maryland
Local Institution
Beverly Hills, California
Local Institution
Boise, Idaho
Local Institution
Boston, Massachusetts
Local Institution
Canton, Ohio
Local Institution
Charlottesville, Virginia
Local Institution
Columbia, Missouri
Local Institution
Columbus, Ohio
Local Institution
Corona, California
Local Institution
Dallas, Texas
Local Institution
Durham, North Carolina
Local Institution
Evanston, Illinois
Local Institution
Goldsboro, North Carolina
Local Institution
Hartford, Connecticut
Local Institution
Hickory, North Carolina
Local Institution
Iowa City, Iowa
Local Institution
Jackson, Mississippi
Local Institution
Kinston, North Carolina
Local Institution
Knoxville, Tennessee
Local Institution
Langhorne, Pennsylvania
Local Institution
Latham, New York
Local Institution
Louisville, Kentucky
Local Institution
Marshfield, Wisconsin
Local Institution
Memphis, Tennessee
Local Institution
Mineola, New York
Local Institution
New York, New York
Local Institution
Norfolk, Virginia
Local Institution
Plantation, Florida
Local Institution
Richmond, Virginia
Local Institution
The Bronx, New York
Local Institution
Tucson, Arizona
Local Institution
Voorhees Township, New Jersey

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France15 sites

Local Institution
Angers
Local Institution
Bordeaux
Local Institution
Caen
Local Institution
Clermont-Ferrand
Local Institution
Colmar
Local Institution
Le Mans
Local Institution
Metz
Local Institution
Paris
Local Institution
Pierre-Bénite
Local Institution
Reims
Local Institution
Saint-Brieuc
Local Institution
Saint-Grégoire
Local Institution
Saint-Herblain
Local Institution
Tours
Local Institution
Villejuif

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Spain15 sites

Local Institution
Barcelona
Local Institution
Cadiz
Local Institution
Córdoba
Local Institution
Elche (Alicante)
Local Institution
Jaén
Local Institution
L'Hospitalet de Llobregat
Local Institution
Madrid
Local Institution
Pontevedra
Local Institution
Reus
Local Institution
Salamanca
Local Institution
Santa Cruz de Tenerife
Local Institution
Seville
Local Institution
Terassa, Barcelona
Local Institution
Valencia
Local Institution
Zaragoza

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Germany13 sites

Local Institution
Berlin
Local Institution
Erlangen
Local Institution
Essen
Local Institution
Hanover
Local Institution
Karlsruhe
Local Institution
Kiel
Local Institution
Marburg
Local Institution
München
Local Institution
Rehling
Local Institution
Saarbrücken
Local Institution
Tübingen
Local Institution
Ulm
Local Institution
Wiesbaden

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Italy12 sites

Local Institution
Bari
Local Institution
Florence
Local Institution
Genova
Local Institution
Milan
Local Institution
Modena
Local Institution
Perugia
Local Institution
Potenza
Local Institution
Roma
Local Institution
Rozzano, Milan
Local Institution
San Giovanni Rotondo
Local Institution
Sora
Local Institution
Torino

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Argentina11 sites

Local Institution
Avellaneda, Buenos Aires
Local Institution
Bahía Blanca, Buenos Aires
Local Institution
Barrio Alto Verde, Córdoba Province
Local Institution
Belen de Escobar, Buenos Aires
Local Institution
Buenos Aires
Local Institution
Ciudad Autonoma de Buenos Aires, Buenos Aires
Local Institution
Mendoza
Local Institution
Resistencia, Chaco Province
Local Institution
Salta
Local Institution
San Miguel de Tucumán, Tucumán Province
Local Institution
Santa Fe

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Australia11 sites

Local Institution
Adelaide, South Australia
Local Institution
Brisbane, Queensland
Local Institution
East Melbourne, Victoria
Local Institution
Herston, Queensland
Local Institution
Parkville, Victoria
Local Institution
Perth, Western Australia
Local Institution
South Brisbane, Queensland
Local Institution
Sydney, New South Wales
Local Institution
Toowoomba, Queensland
Local Institution
Westmead, New South Wales
Local Institution
Woodville, South Australia

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China9 sites

Local Institution
Beijing, Beijing Municipality
Local Institution
Dalian, Liaoning
Local Institution
Dilian, Liaoning
Local Institution
Guangzhou, Guangdong
Local Institution
Hangzhou, Zhejiang
Local Institution
Jinan, Shandong
Local Institution
Nanjing, Jiangsu
Local Institution
Shanghai, Shanghai Municipality
Local Institution
Xi’an, Shanxi

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Belgium6 sites

Local Institution
Brussels
Local Institution
Charleroi
Local Institution
Ghent
Local Institution
Hasselt
Local Institution
Kortrijk
Local Institution
Wilrijk

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Brazil5 sites

Local Institution
Bela Vista, São Paulo
Local Institution
Centro-Porto Alegre, Rio Grande do Sul
Local Institution
Higienopolis, São Paulo
Local Institution
Rio de Janeiro
Local Institution
São Paulo, São Paulo

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United Kingdom5 sites

Local Institution
Belfast, Armagh
Local Institution
Birmingham, West Midlands
Local Institution
Glasgow, Central
Local Institution
London, Greater London
Local Institution
Shrewsbury, Shropshire

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Greece4 sites

Local Institution
Athens
Local Institution
Crete
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Pátrai
Local Institution
Thessaloniki

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Ireland4 sites

Local Institution
Cork
Local Institution
Dublin
Local Institution
Galway
Local Institution
Wilton, Cork

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Israel4 sites

Local Institution
Haifa
Local Institution
Jerusalem
Local Institution
Ramat Gan
Local Institution
Tel Aviv

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Netherlands4 sites

Local Institution
Arnhem
Local Institution
Enschede
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The Hague
Local Institution
Zwolle

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South Africa4 sites

Local Institution
Johannesburg, Gauteng
Local Institution
Panorama, Western Cape
Local Institution
Port Elizabeth, Eastern Cape
Local Institution
Pretoria, Gauteng

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Austria3 sites

Local Institution
Graz
Local Institution
Vienna
Local Institution
Vöcklabruck

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Czechia3 sites

Local Institution
Brno
Local Institution
Hradec Králové
Local Institution
Prague

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Denmark3 sites

Local Institution
Aalborg
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Herlev
Local Institution
København Ø

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Russia3 sites

Local Institution
Kazan'
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Moscow
Local Institution
Saint Petersburg

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South Korea3 sites

Local Institution
Gyeonggi-do
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Incheon
Local Institution
Seoul

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Switzerland3 sites

Local Institution
Bern
Local Institution
Thun
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Zurich

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Turkey (Türkiye)3 sites

Local Institution
Ankara
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Istanbul
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Izmir

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Canada2 sites

Local Institution
Montreal, Quebec
Local Institution
Thunder Bay, Ontario

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Croatia2 sites

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Split
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Zagreb

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Portugal2 sites

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Coimbra
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Lisbon

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Chile1 site

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Santiago, Santiago Metropolitan

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Singapore1 site

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Singapore

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Taiwan1 site

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Taipei

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About this study

Official title: A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane

Conditions: Cancer, Breast Cancer
Being tested: Ixabepilone + Capecitabine, Capecitabine
Medical subject headings: Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ixabepilone + CapecitabineDrug
Also called IXEMPRA®, Epothilone
Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle
CapecitabineDrug
Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle

Study groups in NCT00082433
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: Ixabepilone + Capecitabine
B	Active comparator	Not described Receives: Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival (OS)
Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.
Measured: from date of randomization until death

Secondary outcomes (6)

Progression-Free Survival (PFS)
PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment.
Measured: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Response Rate (RR)
RR=number of patients in that group whose best response is "partial"(30% decrease in the sum of the longest diameter of target lesions) or "complete" (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants
Measured: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Duration of Response
Measured from the time RECIST criteria (described in previous outcome measure) were first met for "complete" or "partial" response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method.
Measured: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Time to Response
Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for "partial" or "complete" (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure).
Measured: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Treatment-Related Safety Summary
Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0
Measured: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.
Measured: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2003Mar 2008

First posted11 May 2004 (estimated)
Study startNov 2003
Primary completionMar 2008
Study completionMar 2008

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.
Publications (4)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,221 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00082433
Sponsor's protocol ID: CA163-048
Status last verified: Oct 2020
First submitted: 7 May 2004
Last updated: 2 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
PubMed 29522361
Vahdat LT, Vrdoljak E, Gomez H, Li RK, Bosserman L, Sparano JA, Baselga J, Mukhopadhyay P, Valero V. Efficacy and safety of ixabepilone plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer. J Geriatr Oncol. 2013 Oct;4(4):346-52. doi: 10.1016/j.jgo.2013.07.006. Epub 2013 Aug 23.
PubMed 24472478
Jassem J, Fein L, Karwal M, Campone M, Peck R, Poulart V, Vahdat L. Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies. Breast. 2012 Feb;21(1):89-94. doi: 10.1016/j.breast.2011.09.003. Epub 2011 Sep 21.
PubMed 21937232
Roche H, Conte P, Perez EA, Sparano JA, Xu B, Jassem J, Peck R, Kelleher T, Hortobagyi GN. Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies. Breast Cancer Res Treat. 2011 Feb;125(3):755-65. doi: 10.1007/s10549-010-1251-y. Epub 2010 Dec 3.
PubMed 21128114

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane
ClinicalTrials.gov ID: NCT00082433
Acronym / sponsor ID: CA163-048
Conditions: Cancer, Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,221 participants (actual)
Lead sponsor: R-PharmIndustry (pharma, biotech, devices)
Study start: Nov 2003
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 11 May 2004 (estimated)
Results: Posted 17 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
A	Experimental	Drug: Ixabepilone + Capecitabine
B	Active comparator	Drug: Capecitabine

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: 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
Ixabepilone + CapecitabineAlso: IXEMPRA®, EpothiloneIxabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle	Drug	A
CapecitabineTablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle	Drug	B

Primary outcome

Overall Survival (OS)
Time frame: from date of randomization until death
Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.

6 secondary outcomes

Progression-Free Survival (PFS)
Time frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Response Rate (RR)
Time frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Duration of Response
Time frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Time to Response
Time frame: every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Treatment-Related Safety Summary
Time frame: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Time frame: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment

Results and safety

Results posted to the registry on 17 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ixabepilone + Capecitabine	609	15
Capecitabine	612	15

Primary outcome: Overall Survival (OS)

Time frame: from date of randomization until death. Median (95% Confidence Interval). Unit: months

Measure	Ixabepilone + Capecitabine n = 609	Capecitabine n = 612
Value	16.39 (14.95 to 17.91)	15.64 (13.86 to 17.02)

Ixabepilone + Capecitabine vs Capecitabine: Hazard Ratio (HR): .90 (95% CI .78 to 1.03), p = .1162, Log Rank
Ixabepilone + Capecitabine vs Capecitabine: Hazard Ratio (HR): .85 (95% CI .75 to .98), p = .0231, Regression, Cox

Population analysed: Analysis was conducted on all randomized patients on an intent to treat basis. This study required at least 846 events (deaths) to ensure the 2-sided, α = 0.05 level, log-rank test to have 90% power to show a statistically significant difference in OS between treatment groups when the hazard ratio (HR) is 0.8.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Capecitabine	192 of 603 (31.8%)	564 of 603 (93.5%)	Not reported
Ixabepilone + Capecitabine	205 of 595 (34.5%)	590 of 595 (99.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29522361Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
Derived from this study: PubMed 24472478Vahdat LT, Vrdoljak E, Gomez H, Li RK, Bosserman L, Sparano JA, Baselga J, Mukhopadhyay P, Valero V. Efficacy and safety of ixabepilone plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer. J Geriatr Oncol. 2013 Oct;4(4):346-52. doi: 10.1016/j.jgo.2013.07.006. Epub 2013 Aug 23.
Derived from this study: PubMed 21937232Jassem J, Fein L, Karwal M, Campone M, Peck R, Poulart V, Vahdat L. Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies. Breast. 2012 Feb;21(1):89-94. doi: 10.1016/j.breast.2011.09.003. Epub 2011 Sep 21.
Derived from this study: PubMed 21128114Roche H, Conte P, Perez EA, Sparano JA, Xu B, Jassem J, Peck R, Kelleher T, Hortobagyi GN. Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies. Breast Cancer Res Treat. 2011 Feb;125(3):755-65. doi: 10.1007/s10549-010-1251-y. Epub 2010 Dec 3.

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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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

186 sites in 29 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ixabepilone + Capecitabine and Capecitabine in people with Cancer and Breast Cancer, run by R-Pharm at 186 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 186 sites in United States, France, Spain, Germany, Italy and 24 more countries. 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. 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 17 Aug 2009). 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?

Overall Survival (OS) (time frame: from date of randomization until death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00082433, which also lists 4 linked publications.

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 2 Nov 2020.