Adenocarcinoma of the ProstatePhase 2NCT00039104
Zoledronate and BMS-275291 in Treating Patients With Prostate Cancer
A Phase 2 study testing rebimastat, zoledronic acid and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of combining zoledronate with BMS-275291 in treating patients who have prostate cancer that has not responded to previous hormone therapy. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Recurrent Prostate Cancer, Stage IV Prostate Cancer
- What is being tested?
- rebimastat, zoledronic acid and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2002to Jan 2005
- Phase
- Phase 2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed (adeno)carcinoma of the prostate refractory to hormone therapy
- Metastatic bone disease, as documented by bone scan and confirmed by x-rays, CT scan or MRI scan
- Note: Patients may also have measurable disease in the lymph nodes (retroperitoneal, pelvic or inguinal only), prostate and /or prostatic bed; measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm =< 21 days prior to registration
- PSA progression defined as two consecutive increases in PSA value over the previous reference value; the first increase of PSA should occur no earlier than one (1) week after the reference measurement; all patients need to demonstrate continued PSA elevation with an increasing PSA four weeks after the required cessation of their antiandrogen treatment; the required cessation period is 4 weeks for flutamide, nilutamide, and Megace-based treatment, and 8 weeks for bicalutamide-based treatment
- One of the following:
- Continuing primary androgen suppression (LHRH agonist)
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- Orchiectomy
- WBC >= 2000/mm^3
- Absolute neutrophil count (ANC) >= 1500/mm^3
- PLT >= 100,000/mm^3
- Hgb >= 9.0 g/dL
- Total bilirubin =< institutional upper normal limits (UNL)
- AST =< 1.5 x UNL
- Serum creatinine =< 1.5 x UNL
- PSA >= 5 ng/mL
- Serum testosterone < 50 ng/dL =< 3 months prior to registration
- Estimated life expectancy of >= 6 months
- ECOG Performance Status (PS) 0, 1, or 2
- Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent
- If sexually active, willing to use an accepted and effective method of contraception consistently for the duration of study participation
Who cannot join
- Any of the following:
- > 2 prior chemotherapy regimen
- > 2 non-hormonal treatments for metastatic disease (including biologics, gene therapy, angiogenesis inhibitors, etc., but excluding external radiotherapy)
- Prior therapy with a matrix metalloproteinase inhibitor (MMPI)
- Immunotherapy =< 4 weeks prior to study entry
- Biologic therapy =< 4 weeks prior to study entry
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- Radiation therapy =< 4 weeks prior to study entry
- Concomitant hormonal treatment (except LHRH)
- Prior use of systemic radiopharmaceuticals such as samarium and strontium
- PC-Spes =< 4 weeks prior to study entry
- Failure to fully recover from adverse effects of prior therapies regardless of interval since last treatment
- Other concurrent chemotherapy, immunotherapy, or radiotherapy directed at the cancer
- Other therapy or supportive care that is considered investigational
- Known CNS metastases
- Known visceral metastases (pulmonary, liver, kidney, splenic lesions); patients with retroperitoneal, pelvic or inguinal lymph node metastases and/or disease in the prostate (or prostatic bed) will not be excluded
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris, cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- HIV-positive patients receiving combination anti-retroviral therapy
- Prior malignancy except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancer from which the patient has been disease free for >= 5 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Open-Label, Randomized Trial of Zoledronic Acid (Zometa™) and BMS-275291 (NSC#713763) in Patients With Hormone Refractory Prostate Cancer
Phase II trial to study the effectiveness of combining zoledronate with BMS-275291 in treating patients who have prostate cancer that has not responded to previous hormone therapy. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. BMS-275291 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Combining zoledronate with BMS-275291 may kill more tumor cells.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the confirmed response rate of hormone refractory prostate cancer patients treated with Zometa with BMS-275291.
SECONDARY OBJECTIVES:
- To evaluate the toxicity profile associated with this treatment in this patient population.
II. To evaluate the overall and progression-free survival associated with this treatment regimen.
III. To explore changes markers for bone turnover, fPYR, fDPYR, and serum samples for cross-linked N-telopeptides from baseline.
IV. To assess changes in bone tumor metabolism after treatment using PET scans. V. To assess changes in MMP-1, MMP-9, VEGF and bFGF from baseline after treatment.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and participating center.
ARM I: Patients receive zoledronate IV over at least 15 minutes on day 1 and oral BMS-275291 daily on days 1-28.
ARM II (CLOSED TO ACCRUAL AS OF 10/10/2003): Patients receive zoledronate as in Arm I.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years.
- Being tested
- rebimastat, zoledronic acid, laboratory biomarker analysis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rebimastatDrug
Also called BMS-275291, D2163
Given PO
zoledronic acidDrug
Also called CGP 42446, CGP42446A, NDC-zoledronate, zoledronate
Given IV
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (rebimastat, zoledronic acid) | Experimental | Patients receive zoledronate IV over at least 15 minutes on day 1 and oral BMS-275291 daily on days 1-28. Receives: Drug: rebimastat; Drug: zoledronic acid; Other: laboratory biomarker analysis |
| Arm II (zoledronic acid) | Experimental | Patients receive zoledronate as in Arm I. Receives: Drug: zoledronic acid; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed response (PSA decline of greater than 50% confirmed at least four weeks apart)
Measured: Up to 2 years
Secondary outcomes (4)
Overall survival time
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Measured: From registration to death due to any cause, assessed for up to 2 years
Time to disease progression
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Measured: From registration to documentation of disease progression, assessed up to 2 years
Duration of PSA response or duration of PSA control
The distribution of this response duration will be estimated using the method of Kaplan-Meier.
Measured: Up to 2 years
Incidence of toxicity as per NCI CTCAE version 2.0
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startApr 2002
- Primary completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Roberto Pili, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00039104
- Sponsor's protocol ID
- NCI-2012-02799
- Other IDs
- MC0151, N01CM17104
- Status last verified
- Jun 2013
- First submitted
- 6 Jun 2002
- Last updated
- 5 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Randomized Trial of Zoledronic Acid (Zometa™) and BMS-275291 (NSC#713763) in Patients With Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00039104
- Acronym / sponsor ID
- NCI-2012-02799
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 2002
- Primary completion
- Jan 2005 (actual)
- First posted
- 27 Jan 2003 (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.
Phase II trial to study the effectiveness of combining zoledronate with BMS-275291 in treating patients who have prostate cancer that has not responded to previous hormone therapy. Zoledronate may prevent bone loss and stop the growth of tumor cells in bone. BMS-275291 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. Combining zoledronate with BMS-275291 may kill more tumor cells.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the confirmed response rate of hormone refractory prostate cancer patients treated with Zometa with BMS-275291.
SECONDARY OBJECTIVES:
- To evaluate the toxicity profile associated with this treatment in this patient population.
II. To evaluate the overall and progression-free survival associated with this treatment regimen.
III. To explore changes markers for bone turnover, fPYR, fDPYR, and serum samples for cross-linked N-telopeptides from baseline.
IV. To assess changes in bone tumor metabolism after treatment using PET scans. V. To assess changes in MMP-1, MMP-9, VEGF and bFGF from baseline after treatment.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to prior chemotherapy (yes vs no) and participating center.
ARM I: Patients receive zoledronate IV over at least 15 minutes on day 1 and oral BMS-275291 daily on days 1-28.
ARM II (CLOSED TO ACCRUAL AS OF 10/10/2003): Patients receive zoledronate as in Arm I.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (rebimastat, zoledronic acid) | Experimental | Drug: rebimastat, Drug: zoledronic acid, Other: laboratory biomarker analysisPatients receive zoledronate IV over at least 15 minutes on day 1 and oral BMS-275291 daily on days 1-28. |
| Arm II (zoledronic acid) | Experimental | Drug: zoledronic acid, Other: laboratory biomarker analysisPatients receive zoledronate as in Arm I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically or cytologically confirmed (adeno)carcinoma of the prostate refractory to hormone therapy
- Metastatic bone disease, as documented by bone scan and confirmed by x-rays, CT scan or MRI scan
- PSA progression defined as two consecutive increases in PSA value over the previous reference value; the first increase of PSA should occur no earlier than one (1) week after the reference measurement; all patients need to demonstrate continued PSA elevation with an increasing PSA four weeks after the required cessation of their antiandrogen treatment; the required cessation period is 4 weeks for flutamide, nilutamide, and Megace-based treatment, and 8 weeks for bicalutamide-based treatment
- One of the following:
- WBC >= 2000/mm^3
Key exclusion criteria (22 listed)
- Any of the following:
- Known CNS metastases
- Known visceral metastases (pulmonary, liver, kidney, splenic lesions); patients with retroperitoneal, pelvic or inguinal lymph node metastases and/or disease in the prostate (or prostatic bed) will not be excluded
- Uncontrolled intercurrent illness including, but not limited to:
- HIV-positive patients receiving combination anti-retroviral therapy
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 |
|---|---|---|
| rebimastatAlso: BMS-275291, D2163Given PO | Drug | Arm I (rebimastat, zoledronic acid) |
| zoledronic acidAlso: CGP 42446, CGP42446A, NDC-zoledronate, zoledronateGiven IV | Drug | Arm I (rebimastat, zoledronic acid), Arm II (zoledronic acid) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (rebimastat, zoledronic acid), Arm II (zoledronic acid) |
Primary outcome
Confirmed response (PSA decline of greater than 50% confirmed at least four weeks apart)
Time frame: Up to 2 years
4 secondary outcomes
Overall survival time
Time frame: From registration to death due to any cause, assessed for up to 2 years
Time to disease progression
Time frame: From registration to documentation of disease progression, assessed up to 2 years
Duration of PSA response or duration of PSA control
Time frame: Up to 2 years
Incidence of toxicity as per NCI CTCAE version 2.0
Time frame: Up to 2 years
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 5 Jun 2013.
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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.
Roberto Pili principal investigator
Mayo Clinic
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 rebimastat, zoledronic acid and laboratory biomarker analysis in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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 20 inclusion and 22 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 5 Jun 2013. 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 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. 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?
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?
Confirmed response (PSA decline of greater than 50% confirmed at least four weeks apart) (time frame: Up to 2 years). 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 5 Jun 2013.