Nasopharyngeal CancerPhase 2NCT00697619
To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer
A Phase 2 study testing Zometa (zoledronic acid) in people with Nasopharyngeal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasopharyngeal Cancer
- What is being tested?
- Zometa (zoledronic acid)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2005to Sep 2009
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18, either sex
- Histologically confirmed stage IV nasopharyngeal cancer
- One bone metastasis at least confirmed by imaging
- without chemotherapy or radiotherapy after bone metastasis
- Life expectancy > 6 M
- ECOG <= 2
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- Adequate bone marrow reserve (WBC > 3.5 x 109/L, Neutrophile > 1.5 x 109/L, Platelet 100 x 109/L, Hb > 90 g/L)
- Serum creatinine< 2.0 mg/dL (< 1.5 times the upper limit of the normal range for the laboratory of the study center)
- Signed ICF
Who cannot join
- Women who are pregnant or in lactation
- Patients with hyperostosis
- Systemic treatment for another cancer within the year prior to study entry
- Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
- Initial serum creatinine >265 micromol/L and/or progressive renal disease
- Known hypersensitivity to any of the study drugs or to drugs with similar chemical structures
- Use of investigational agents within 28 days of the Baseline visit, or participating simultaneously in any other clinical studies
- Severe co-morbidity of any type that may interfere with assessment of the patient for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-label, Randomized Phase III Study to Evaluate the Efficacy of ZOMETA® (Zoledronic Acid) in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer
The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic treatment alone.
- Conditions
- Nasopharyngeal Cancer
- Being tested
- Zometa (zoledronic acid)
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zometa (zoledronic acid)Drug
Also called Zometa
Zometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy. Receives: Drug: Zometa (zoledronic acid) |
| Contorl Group | No intervention | Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .
Measured: Baseline, the first, second and third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startSep 2005
- Primary completionJan 2009
- Study completionSep 2009
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 Nasopharyngeal CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Li Zhang, Sun Yat-sen University
- Investigators
- Li Zhang, Master, Principal investigator, Cancer Center of Sun Yat-Sen University (CCSU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697619
- Sponsor's protocol ID
- CZOL446ECN02
- Status last verified
- Dec 2011
- First submitted
- 11 Jun 2008
- Last updated
- 7 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Randomized Phase III Study to Evaluate the Efficacy of ZOMETA® (Zoledronic Acid) in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT00697619
- Acronym / sponsor ID
- CZOL446ECN02
- Conditions
- Nasopharyngeal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Sep 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Jun 2008 (estimated)
- Results
- Posted 2 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy of addition of zometa to anti-neoplastic treatment compared with anti-neoplastic treatment alone, as measured by the primary efficacy variable of SREs (Skeletal Related Events) and to assess the safety in nasopharyngeal patients with bone metastases randomized to receive either zometa 4 mg or anti-neoplastic treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Zometa (zoledronic acid)Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy. |
| Contorl Group | No intervention | –Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age >18, either sex
- Histologically confirmed stage IV nasopharyngeal cancer
- One bone metastasis at least confirmed by imaging
- without chemotherapy or radiotherapy after bone metastasis
- Life expectancy > 6 M
Key exclusion criteria (8 listed)
- Women who are pregnant or in lactation
- Patients with hyperostosis
- Systemic treatment for another cancer within the year prior to study entry
- Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
- Initial serum creatinine >265 micromol/L and/or progressive renal disease
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 |
|---|---|---|
| Zometa (zoledronic acid)Also: ZometaZometa 4 mg IV infusion every 4 weeks for 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily | Drug | Test Group |
Primary outcome
Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .
Time frame: Baseline, the first, second and third month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
- 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.
Li Zhang, Master principal investigator
Cancer Center of Sun Yat-Sen University (CCSU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zometa (zoledronic acid) in people with Nasopharyngeal Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. 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 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 2 Mar 2012). 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?
Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms . (time frame: Baseline, the first, second and third month). 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 7 Mar 2012.