Renal Cell CancerPhase 4NCT00172003
Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis
A Phase 4 study testing Zoledronic acid in people with Renal Cell Cancer and Neoplasm Metastasis, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial summary
It is the aim of this clinical study to evaluate the skeletal-related event rate under therapy with zoledronic acid in patients with renal cell cancer having at least one cancer-related bone lesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Cancer, Neoplasm Metastasis
- What is being tested?
- Zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2004to Jul 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A histologically confirmed diagnosis of renal cell carcinoma with none, one or, at maximum, 2 of the following risk factors:
- Karnofsky performance status less than 80%
- Lactate dehydrogenase greater than 1.5 times upper limit of normal
- Hemoglobin less than lower limit of normal
- Absence of nephrectomy
- Patients must have evidence of at least one cancer-related bone lesion. If diagnosis of bone metastases in bone scan or magnetic resonance imaging (MRI)-QuickScan is unclear radiographic (X-ray, computed tomography [CT] or MRI) confirmation of at least one focus is required.
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- ECOG performance status of 0, 1 or 2.
- Life expectancy of ≥ 6 months
- Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value
- Patient has given written informed consent prior to any study-specific procedures
Who cannot join
- Only patients who received 3 or less applications of an i.v. Bisphosphonate in the past are eligible
- Previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) is allowed. However, other loci of bone metastasis must be present, which were not treated with radiation therapy and thus can be assessed for primary and secondary endpoints.
- Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula: CrCl = [140-age (years)] x weight (kg) {x 0.85 for female patients} [72 x serum creatinine (mg/dL)]
- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L)
- Patients with clinically symptomatic brain metastases
- History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism
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- Severe physical or psychological concomitant diseases that might impair compliance with the provisions of the study protocol or that might impair the assessment of drug or patient safety, e.g. clinically significant ascites, cardiac failure, NYHA III or IV, clinically relevant pathologic findings in ECG.
- Known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates
- Pregnancy and lactation
- Women of childbearing potential not on a medically recognized form of contraception (i.e., oral contraceptives or implants, intrauterine device [IUD], vaginal diaphragm or sponge, or condom with spermicide)
- Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of study inclusion
- Use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of study inclusion
- Participation in another trial
- Known history or present abuse of alcohol or drugs (accepted social alcohol usage will not exclude the patient)
- Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
- Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
- Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)
- Other protocol-defined inclusion and exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
It is the aim of this clinical study to evaluate the skeletal-related event rate under therapy with zoledronic acid in patients with renal cell cancer having at least one cancer-related bone lesion.
- Conditions
- Renal Cell Cancer, Neoplasm Metastasis
- Being tested
- Zoledronic acid
- Keywords
- Renal Cell Cancer, Bone metastasis, Skeletal related event, Renal Cell Cancer patients with bone metastasis
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acidDrug
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic acid | Experimental | Zoledronic acid, dosage according to calculated creatinine clearance, administered as a 15 minute infusion every 3 weeks for 12 months. Study infusion visits should occur not earlier than the scheduled visit and no later than 3 days after the scheduled visit. The dose of zoledronic acid in patients with baseline creatinine clearance > 60 mL/min was recommended to be 4 mg infused over no less than 15 minutes. Receives: Drug: Zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of skeletal complications
Measured: continuous
Secondary outcomes (5)
Time to first skeletal complication
Measured: from first application of Zometa until confirmed skeletal related event (SRE)
Bone pain
Measured: every 9 weeks
Time to overall progression of disease
Measured: continuous
Overall survival
Measured: continuous
Bone turnover parameters
Measured: every 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00172003
- Sponsor's protocol ID
- CZOL446EDE15
- Status last verified
- Nov 2016
- First submitted
- 13 Sep 2005
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tunn UW, Stenzl A, Schultze-Seemann W, Strauss A, Kindler M, Miller K, Wirth MP, Zantl N, Schulze M, May C, Ruebel A, Birkholz K, Gruenwald V. Positive effects of zoledronate on skeletal-related events in patients with renal cell cancer and bone metastases. Can J Urol. 2012 Jun;19(3):6261-7.
PubMed 22704310
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zoledronic Acid in Patients With Renal Cell Cancer and Bone Metastasis
- ClinicalTrials.gov ID
- NCT00172003
- Acronym / sponsor ID
- CZOL446EDE15
- Conditions
- Renal Cell Cancer, Neoplasm Metastasis
- Keywords
- Renal Cell Cancer, Bone metastasis, Skeletal related event, Renal Cell Cancer patients with bone metastasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is the aim of this clinical study to evaluate the skeletal-related event rate under therapy with zoledronic acid in patients with renal cell cancer having at least one cancer-related bone lesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zoledronic acid | Experimental | Drug: Zoledronic acidZoledronic acid, dosage according to calculated creatinine clearance, administered as a 15 minute infusion every 3 weeks for 12 months. Study infusion visits should occur not earlier than the scheduled visit and no later than 3 days after the scheduled visit. The dose of zoledronic acid in patients with baseline creatinine clearance > 60 mL/min was recommended to be 4 mg infused over no less than 15 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A histologically confirmed diagnosis of renal cell carcinoma with none, one or, at maximum, 2 of the following risk factors:
- Patients must have evidence of at least one cancer-related bone lesion. If diagnosis of bone metastases in bone scan or magnetic resonance imaging (MRI)-QuickScan is unclear radiographic (X-ray, computed tomography [CT] or MRI) confirmation of at least one focus is required.
- ECOG performance status of 0, 1 or 2.
- Life expectancy of ≥ 6 months
- Adequate liver function - serum total bilirubin concentration less than 1.5 x upper limit of normal value
Key exclusion criteria (18 listed)
- Only patients who received 3 or less applications of an i.v. Bisphosphonate in the past are eligible
- Previous radiation therapy to bone (including therapeutic radioisotopes such as strontium 89) is allowed. However, other loci of bone metastasis must be present, which were not treated with radiation therapy and thus can be assessed for primary and secondary endpoints.
- Abnormal renal function as evidenced by a calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula: CrCl = [140-age (years)] x weight (kg) {x 0.85 for female patients} [72 x serum creatinine (mg/dL)]
- Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L) or ≥ 12.0 mg/dl (3.00 mmol/L)
- Patients with clinically symptomatic brain metastases
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 |
|---|---|---|
| Zoledronic acid | Drug | Zoledronic acid |
Primary outcome
Rate of skeletal complications
Time frame: continuous
5 secondary outcomes
Time to first skeletal complication
Time frame: from first application of Zometa until confirmed skeletal related event (SRE)
Bone pain
Time frame: every 9 weeks
Time to overall progression of disease
Time frame: continuous
Overall survival
Time frame: continuous
Bone turnover parameters
Time frame: every 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Results publication: PubMed 22704310Tunn UW, Stenzl A, Schultze-Seemann W, Strauss A, Kindler M, Miller K, Wirth MP, Zantl N, Schulze M, May C, Ruebel A, Birkholz K, Gruenwald V. Positive effects of zoledronate on skeletal-related events in patients with renal cell cancer and bone metastases. Can J Urol. 2012 Jun;19(3):6261-7.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmeceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoledronic acid in people with Renal Cell Cancer and Neoplasm Metastasis, run by Novartis Pharmaceuticals at 1 site in Germany.
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 10 inclusion and 18 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 18 Nov 2016. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of skeletal complications (time frame: continuous). 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 NCT00172003, which also lists 1 linked publication.
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 18 Nov 2016.