Bone MetastasesPhase 1NCT00264420
Safety and Efficacy Study of Concomitant Radiotherapy and Zoledronic Acid for Bone Metastases Palliation
A Phase 1 study testing zoledronic acid in people with Bone Metastases and Breast Cancer, run by The Cleveland Clinic.
Trial summary
Zoledronic acid (Zometa) belongs to a class of drugs called bisphosphonates. Bisphosphonates are used in bone metastases to keep the cancerous lesion under control in the bone and to help prevent calcium level elevations in the blood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases, Breast Cancer, Lung Cancer
- 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
- 4 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Mar 2007
- Phase
- Phase 1
- 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
- >18 years of age
- biopsy proven breast, lung, and/or prostate cancer
- boney metastases with an indication for radiation, either diagnosed radiologically or biopsy proven
- Karnofsky Performance Status >60
- Life expectancy of at least 6 months
- Serum creatinine level ≤ 2.0 mg/dL and calculated creatinine clearance of > 60 mL/min
Show all 10Show fewer
- Leukocyte count ≥ 3500/mm3
- Hemoglobulin > 11 g/dl
- Platelets > 100,000 / mm3
- Total bilirubin < 2.5 mg/dl
Who cannot join
- pregnant and lactating women (breast and lung cancer)
- hormonotherapy started less than 3 months prior to randomization (prostate cancer)
- history of allergic reactions to bisphosphonates
- receiving concomitant nephrotoxic chemotherapy
- participation in another clinical trial with an investigational drug or completed an investigational drug trial within the past 30 days
- liver function tests > 1.5 times normal values
Show all 17Show fewer
- IV calcitonin administration less than 30 days prior to randomization
- laboratory evidence of renal disease
- previous RT to the region of bone metastasis which will be treated in this study
- currently receiving oral or IV bisphosphonate therapy
- presence of ascites
- clinically significant electrocardiographic changes
- hypercalcemia, pathologic fracture, or epidural spinal cord compression
- other organ metastasis
- known hypersensitivity to Zometa® (zoledronic acid) or other bisphosphonates
- 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)
About this study
Official title: A Phase I Pilot Trial to Study the Safety and Efficacy of Concomitant Radiotherapy and Zoledronic Acid for the Palliation of Bone Metastases From Breast Cancer, Prostate Cancer and Lung Cancer
Zoledronic acid (Zometa) belongs to a class of drugs called bisphosphonates. Bisphosphonates are used in bone metastases to keep the cancerous lesion under control in the bone and to help prevent calcium level elevations in the blood. Cancer cell-culture studies at the Cleveland Clinic showed that zoledronic acid and radiation together have more cell killing effect than either one used alone. The purpose of this study is to monitor the healing of bone lesions when using zoledronic acid together with radiation treatment.
Read the detailed description
Bone metastases are frequently one of the first signs of disseminated disease in cancer patients. Skeletal complications due to metastatic disease include (severe) bone pain, impaired mobility, spinal cord compression, pathological fractures, and hypercalcemia. Radiotherapy and surgery are the options for the specific local treatment of bone metastases. Chemotherapy, hormonotherapy and bisphosphonates are systemic weapons used in the treatment of bone metastases with or without hypercalcemia. Cancers with propensity to metastasize to bones such as breast, prostate, lung and myeloma may possess the capacity to interact with osteoclasts. Osteoclasts are specialized bone cells, which erode mineralized bone by secreting acids and lysosomal enzymes. In normal bone remodeling, osteoclastic bone resorption is coupled to and is in equilibrium with osteoblastic bone formation. The lytic bone destruction associated with malignant bone metastases develops because tumor cells synthesize and release soluble factors that stimulate osteoclasts to resorb bone. The malignant activation of osteoclasts results in a disruption of normal bone remodeling wherein the equilibrium between bone resorption and bone formation is shifted toward increased bone resorption. This relative increase in osteoclastic bone resorption results in a net loss of bone.
Zoledronic acid (Zometa®, CGP42446) is a member of a class of compounds known as bisphosphonates. Bisphosphonates are effective inhibitors of osteoclastic bone resorption. They have therapeutic efficacy in the treatments of hypercalcemia of malignancy, lytic bone disease associated with multiple myeloma, and mixed lytic and blastic bone metastases associated with breast cancer, prostate cancer and lung cancer. In the clinical setting, zoledronic acid is the most potent bisphosphonate.
Conventionally, external beam radiotherapy (RT) is a primary treatment method for the palliation of bone metastases. The aim of RT in bone metastases treatment is to eradicate malignant cells without damaging surrounding normal cells. RT is typically given to the lesion area, in order to spare as much bone marrow as possible. RT is indicated in solitary, lytic and painful bone lesions of multiple myeloma as well as bone metastases from solid tumors such as breast, prostate and lung cancer to prevent the fracture risk or to relieve the pain.
The goal of this study will be to evaluate the safety and efficacy of concomitant standard RT and standard zoledronic acid on the bone metastases of breast, prostate or lung cancer patients. We chose zoledronic acid to use in this study, as it is the most effective FDA approved aminobisphosphonate.
- Conditions
- Bone Metastases, Breast Cancer, Lung Cancer, Prostate Cancer
- Being tested
- zoledronic acid
- Keywords
- bone metastases, breast cancer, lung cancer, prostate cancer, zoledronic acid, radiation therapy
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zoledronic acidDrug
At baseline 4 mg IV zoledronic acid over 15 min. every 4 weeks for 6 months plus radiation therapy 30 Gy in 10 fractions (5 times per week for first two weeks)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | zoledronic acid plus radiation therapy Receives: Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET-CT
Measured: baseline and 6 months
Secondary outcomes (3)
X-ray, baseline
Measured: 3 months, 6 months
physical exam
Measured: Radiaton Oncology - visits 1, 14, 17
physical exam
Measured: Medical Oncology - visits 1, 13, 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startDec 2005
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (120)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Investigators
- Roger Macklis, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264420
- Sponsor's protocol ID
- IRB7743
- Other IDs
- Case 8Y04
- Status last verified
- Dec 2010
- First submitted
- 6 Dec 2005
- Last updated
- 21 Dec 2010
- Results posted
- No
Publications
Fulfaro F, Casuccio A, Ticozzi C, Ripamonti C. The role of bisphosphonates in the treatment of painful metastatic bone disease: a review of phase III trials. Pain. 1998 Dec;78(3):157-169. doi: 10.1016/S0304-3959(98)00135-3.
PubMed 9870569ABRAMS HL, SPIRO R, GOLDSTEIN N. Metastases in carcinoma; analysis of 1000 autopsied cases. Cancer. 1950 Jan;3(1):74-85. doi: 10.1002/1097-0142(1950)3:13.0.co;2-7. No abstract available.
PubMed 15405683Scher HI, Chung LW. Bone metastases: improving the therapeutic index. Semin Oncol. 1994 Oct;21(5):630-56. No abstract available.
PubMed 7939753Brown JE, Neville-Webbe H, Coleman RE. The role of bisphosphonates in breast and prostate cancers. Endocr Relat Cancer. 2004 Jun;11(2):207-24. doi: 10.1677/erc.0.0110207.
PubMed 15163299Lipton A, Berenson JR. Bisphosphonate treatment of lytic bone metastases. Drugs Aging. 1999 Apr;14(4):241-6. doi: 10.2165/00002512-199914040-00001.
PubMed 10319239Body JJ. Clinical research update: zoledronate. Cancer. 1997 Oct 15;80(8 Suppl):1699-701. doi: 10.1002/(sici)1097-0142(19971015)80:8+3.3.co;2-a.
PubMed 9362440Mundy GR, Wilkinson R, Heath DA. Comparative study of available medical therapy for hypercalcemia of malignancy. Am J Med. 1983 Mar;74(3):421-32. doi: 10.1016/0002-9343(83)90961-0.
PubMed 6219578Ralston SH, Gallacher SJ, Patel U, Dryburgh FJ, Fraser WD, Cowan RA, Boyle IT. Comparison of three intravenous bisphosphonates in cancer-associated hypercalcaemia. Lancet. 1989 Nov 18;2(8673):1180-2. doi: 10.1016/s0140-6736(89)91791-1.
PubMed 2572902Cantwell BM, Harris AL. Effect of single high dose infusions of aminohydroxypropylidene diphosphonate on hypercalcaemia caused by cancer. Br Med J (Clin Res Ed). 1987 Feb 21;294(6570):467-9. doi: 10.1136/bmj.294.6570.467.
PubMed 3103730Thiebaud D, Jaeger P, Jacquet AF, Burckhardt P. Dose-response in the treatment of hypercalcemia of malignancy by a single infusion of the bisphosphonate AHPrBP. J Clin Oncol. 1988 May;6(5):762-8. doi: 10.1200/JCO.1988.6.5.762.
PubMed 3367184Guise TA. Molecular mechanisms of osteolytic bone metastases. Cancer. 2000 Jun 15;88(12 Suppl):2892-8. doi: 10.1002/1097-0142(20000615)88:12+3.0.co;2-y.
PubMed 10898330Thomas RJ, Guise TA, Yin JJ, Elliott J, Horwood NJ, Martin TJ, Gillespie MT. Breast cancer cells interact with osteoblasts to support osteoclast formation. Endocrinology. 1999 Oct;140(10):4451-8. doi: 10.1210/endo.140.10.7037.
PubMed 10499498Gucalp R, Ritch P, Wiernik PH, Sarma PR, Keller A, Richman SP, Tauer K, Neidhart J, Mallette LE, Siegel R, et al. Comparative study of pamidronate disodium and etidronate disodium in the treatment of cancer-related hypercalcemia. J Clin Oncol. 1992 Jan;10(1):134-42. doi: 10.1200/JCO.1992.10.1.134.
PubMed 1727915Nussbaum SR, Younger J, Vandepol CJ, Gagel RF, Zubler MA, Chapman R, Henderson IC, Mallette LE. Single-dose intravenous therapy with pamidronate for the treatment of hypercalcemia of malignancy: comparison of 30-, 60-, and 90-mg dosages. Am J Med. 1993 Sep;95(3):297-304. doi: 10.1016/0002-9343(93)90282-t.
PubMed 8368227Elomaa I, Blomqvist C, Grohn P, Porkka L, Kairento AL, Selander K, Lamberg-Allardt C, Holmstrom T. Long-term controlled trial with diphosphonate in patients with osteolytic bone metastases. Lancet. 1983 Jan 22;1(8317):146-9. doi: 10.1016/s0140-6736(83)92755-1.
PubMed 6130197
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pilot Trial to Study the Safety and Efficacy of Concomitant Radiotherapy and Zoledronic Acid for the Palliation of Bone Metastases From Breast Cancer, Prostate Cancer and Lung Cancer
- ClinicalTrials.gov ID
- NCT00264420
- Acronym / sponsor ID
- IRB7743
- Conditions
- Bone Metastases, Breast Cancer, Lung Cancer, Prostate Cancer
- Keywords
- bone metastases, breast cancer, lung cancer, prostate cancer, zoledronic acid, radiation therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Dec 2005
- Study completion
- Mar 2007 (actual)
- First posted
- 12 Dec 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.
Zoledronic acid (Zometa) belongs to a class of drugs called bisphosphonates. Bisphosphonates are used in bone metastases to keep the cancerous lesion under control in the bone and to help prevent calcium level elevations in the blood. Cancer cell-culture studies at the Cleveland Clinic showed that zoledronic acid and radiation together have more cell killing effect than either one used alone. The purpose of this study is to monitor the healing of bone lesions when using zoledronic acid together with radiation treatment.
Detailed description
Bone metastases are frequently one of the first signs of disseminated disease in cancer patients. Skeletal complications due to metastatic disease include (severe) bone pain, impaired mobility, spinal cord compression, pathological fractures, and hypercalcemia. Radiotherapy and surgery are the options for the specific local treatment of bone metastases. Chemotherapy, hormonotherapy and bisphosphonates are systemic weapons used in the treatment of bone metastases with or without hypercalcemia. Cancers with propensity to metastasize to bones such as breast, prostate, lung and myeloma may possess the capacity to interact with osteoclasts. Osteoclasts are specialized bone cells, which erode mineralized bone by secreting acids and lysosomal enzymes. In normal bone remodeling, osteoclastic bone resorption is coupled to and is in equilibrium with osteoblastic bone formation. The lytic bone destruction associated with malignant bone metastases develops because tumor cells synthesize and release soluble factors that stimulate osteoclasts to resorb bone. The malignant activation of osteoclasts results in a disruption of normal bone remodeling wherein the equilibrium between bone resorption and bone formation is shifted toward increased bone resorption. This relative increase in osteoclastic bone resorption results in a net loss of bone.
Zoledronic acid (Zometa®, CGP42446) is a member of a class of compounds known as bisphosphonates. Bisphosphonates are effective inhibitors of osteoclastic bone resorption. They have therapeutic efficacy in the treatments of hypercalcemia of malignancy, lytic bone disease associated with multiple myeloma, and mixed lytic and blastic bone metastases associated with breast cancer, prostate cancer and lung cancer. In the clinical setting, zoledronic acid is the most potent bisphosphonate.
Conventionally, external beam radiotherapy (RT) is a primary treatment method for the palliation of bone metastases. The aim of RT in bone metastases treatment is to eradicate malignant cells without damaging surrounding normal cells. RT is typically given to the lesion area, in order to spare as much bone marrow as possible. RT is indicated in solitary, lytic and painful bone lesions of multiple myeloma as well as bone metastases from solid tumors such as breast, prostate and lung cancer to prevent the fracture risk or to relieve the pain.
The goal of this study will be to evaluate the safety and efficacy of concomitant standard RT and standard zoledronic acid on the bone metastases of breast, prostate or lung cancer patients. We chose zoledronic acid to use in this study, as it is the most effective FDA approved aminobisphosphonate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: zoledronic acidzoledronic acid plus radiation therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- >18 years of age
- biopsy proven breast, lung, and/or prostate cancer
- boney metastases with an indication for radiation, either diagnosed radiologically or biopsy proven
- Karnofsky Performance Status >60
- Life expectancy of at least 6 months
Key exclusion criteria (17 listed)
- pregnant and lactating women (breast and lung cancer)
- hormonotherapy started less than 3 months prior to randomization (prostate cancer)
- history of allergic reactions to bisphosphonates
- receiving concomitant nephrotoxic chemotherapy
- participation in another clinical trial with an investigational drug or completed an investigational drug trial within the past 30 days
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 acidAt baseline 4 mg IV zoledronic acid over 15 min. every 4 weeks for 6 months plus radiation therapy 30 Gy in 10 fractions (5 times per week for first two weeks) | Drug | 1 |
Primary outcome
PET-CT
Time frame: baseline and 6 months
3 secondary outcomes
X-ray, baseline
Time frame: 3 months, 6 months
physical exam
Time frame: Radiaton Oncology - visits 1, 14, 17
physical exam
Time frame: Medical Oncology - visits 1, 13, 17
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 21 Dec 2010.
- Background: PubMed 9870569Fulfaro F, Casuccio A, Ticozzi C, Ripamonti C. The role of bisphosphonates in the treatment of painful metastatic bone disease: a review of phase III trials. Pain. 1998 Dec;78(3):157-169. doi: 10.1016/S0304-3959(98)00135-3.
- Background: PubMed 15405683ABRAMS HL, SPIRO R, GOLDSTEIN N. Metastases in carcinoma; analysis of 1000 autopsied cases. Cancer. 1950 Jan;3(1):74-85. doi: 10.1002/1097-0142(1950)3:13.0.co;2-7. No abstract available.
- Background: PubMed 7939753Scher HI, Chung LW. Bone metastases: improving the therapeutic index. Semin Oncol. 1994 Oct;21(5):630-56. No abstract available.
- Background: PubMed 15163299Brown JE, Neville-Webbe H, Coleman RE. The role of bisphosphonates in breast and prostate cancers. Endocr Relat Cancer. 2004 Jun;11(2):207-24. doi: 10.1677/erc.0.0110207.
- Background: PubMed 10319239Lipton A, Berenson JR. Bisphosphonate treatment of lytic bone metastases. Drugs Aging. 1999 Apr;14(4):241-6. doi: 10.2165/00002512-199914040-00001.
- Background: PubMed 9362440Body JJ. Clinical research update: zoledronate. Cancer. 1997 Oct 15;80(8 Suppl):1699-701. doi: 10.1002/(sici)1097-0142(19971015)80:8+3.3.co;2-a.
- Background: PubMed 6219578Mundy GR, Wilkinson R, Heath DA. Comparative study of available medical therapy for hypercalcemia of malignancy. Am J Med. 1983 Mar;74(3):421-32. doi: 10.1016/0002-9343(83)90961-0.
- Background: PubMed 2572902Ralston SH, Gallacher SJ, Patel U, Dryburgh FJ, Fraser WD, Cowan RA, Boyle IT. Comparison of three intravenous bisphosphonates in cancer-associated hypercalcaemia. Lancet. 1989 Nov 18;2(8673):1180-2. doi: 10.1016/s0140-6736(89)91791-1.
- Background: PubMed 3103730Cantwell BM, Harris AL. Effect of single high dose infusions of aminohydroxypropylidene diphosphonate on hypercalcaemia caused by cancer. Br Med J (Clin Res Ed). 1987 Feb 21;294(6570):467-9. doi: 10.1136/bmj.294.6570.467.
- Background: PubMed 3367184Thiebaud D, Jaeger P, Jacquet AF, Burckhardt P. Dose-response in the treatment of hypercalcemia of malignancy by a single infusion of the bisphosphonate AHPrBP. J Clin Oncol. 1988 May;6(5):762-8. doi: 10.1200/JCO.1988.6.5.762.
- Background: PubMed 10898330Guise TA. Molecular mechanisms of osteolytic bone metastases. Cancer. 2000 Jun 15;88(12 Suppl):2892-8. doi: 10.1002/1097-0142(20000615)88:12+3.0.co;2-y.
- Background: PubMed 10499498Thomas RJ, Guise TA, Yin JJ, Elliott J, Horwood NJ, Martin TJ, Gillespie MT. Breast cancer cells interact with osteoblasts to support osteoclast formation. Endocrinology. 1999 Oct;140(10):4451-8. doi: 10.1210/endo.140.10.7037.
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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.
Roger Macklis, MD principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing zoledronic acid in people with Bone Metastases and Breast Cancer, run by The Cleveland Clinic.
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 17 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 21 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
PET-CT (time frame: baseline and 6 months). 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 NCT00264420, which also lists 120 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 21 Dec 2010.