Prostatic NeoplasmsPhase 1/2NCT00121095
Study of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Prostate Cancer
A Phase 1/2 study testing Samarium Sm-153 lexidronam + Docetaxel in people with Prostatic Neoplasms, run by Cytogen Corporation at 1 site in United States.
Trial summary
The purpose of this study is to investigate the safety, tolerability and anti-tumor effects of treatment with samarium Sm-153 lexidronam in combination with docetaxel in patients with castrate metastatic prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Samarium Sm-153 lexidronam + Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jun 2008
- Phase
- Phase 1/2
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have histological evidence of adenocarcinoma of the prostate.
- Have progressive castrate metastatic disease.
- Castrate levels of testosterone (<50 ng/ml). Treatment to maintain castrate levels of testosterone must be continued.
- Must have evidence of at least 3 bone metastases on bone scan.
- Patients for whom initial hormone treatment (exclusive of neoadjuvant hormone therapy) was a combined androgen blockade approach, must show progression of disease following withdrawal of the anti-androgen prior to enrollment.
- Patients undergoing prior bisphosphonate treatments are eligible.
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- Patients who have received one prior treatment with 153Sm lexidronam or 89Sr are eligible provided it is at least 12 weeks from treatment with 153Sm lexidronam or 24 weeks from treatment with 89Sr.
- Life expectancy of at least 12 weeks (based on co-morbidity).
- KPS>60.
- Lab requirements:
- White Blood Count (WBC) ≥ 3,000/mm3;
- Absolute Neutrophil Count (ANC) ≥ 1,500/ mm3;
- Platelet (PLT) ≥ 100,000/mm3;
- Hemoglobin (HGB) ≥ 10 mg/dl;
- Bilirubin ≤ 2.0 mg/dl;
- ALT/AST≤ 3 times the upper limit of normal;
- Serum creatinine ≤ 2.0 mg/dl.
- Patients must sign an informed consent.
Who cannot join
- Patients with small cell carcinoma.
- Patients with predominant visceral metastases (>3 lung or liver lesions) or symptomatic lymphadenopathy (scrotal or pedal edema).
- Patients who have received more than one course of external beam radiation therapy directed at bone lesions.
- Clinically significant cardiac disease (New York Heart Association Class III/IV).
- History of other malignancies (other than non-melanoma skin cancer), unless in complete remission or off therapy for that disease for at least five years.
- Have or are participating in a research study protocol or clinical trial protocol within 30 days of the date of the baseline visit.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Michael J Morris, 646-422-4469
Michael J Morris, MD
About this study
Official title: Phase I/II Trial of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Androgen-Independent Prostate Cancer
The purpose of this study is to investigate the safety, tolerability and anti-tumor effects of treatment with samarium Sm-153 lexidronam in combination with docetaxel in patients with castrate metastatic prostate cancer.
Read the detailed description
The principal objective of this trial is to evaluate the safety, feasibility, and anti-tumor effects of a novel bone-targeted regimen consisting of Samarium Sm-153 lexidronam combined with docetaxel and prednisone. This present study design permits evaluation of the clinical activity of combining two distinct agents that have shown benefit for the treatment of patients with advanced androgen-independent prostate cancer and bone metastases. It enables assessment of potential synergistic interactions between a cytotoxic chemotherapy agent and a bone-targeting radioisotope agent in the setting of a bone-targeted therapy.
- Conditions
- Prostatic Neoplasms
- Being tested
- Samarium Sm-153 lexidronam + Docetaxel
- Keywords
- prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samarium Sm-153 lexidronam + DocetaxelDrug
1 mCi/kg Sm153 + 75 mg/m2 docetaxel
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: Samarium Sm-153 lexidronam + Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome is safety and tolerability of the combination treatment
Secondary outcomes (1)
Tumor response will be assessed when possible using RECIST criteria.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJul 2005
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytogen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael J Morris, M.D., Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121095
- Sponsor's protocol ID
- 424Sm32
- Status last verified
- Dec 2007
- First submitted
- 13 Jul 2005
- Last updated
- 21 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial of Samarium Sm-153 Lexidronam Combined With Docetaxel for Patients With Androgen-Independent Prostate Cancer
- ClinicalTrials.gov ID
- NCT00121095
- Acronym / sponsor ID
- 424Sm32
- Conditions
- Prostatic Neoplasms
- Keywords
- prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Cytogen CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Jun 2008 (estimated)
- First posted
- 21 Jul 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.
The purpose of this study is to investigate the safety, tolerability and anti-tumor effects of treatment with samarium Sm-153 lexidronam in combination with docetaxel in patients with castrate metastatic prostate cancer.
Detailed description
The principal objective of this trial is to evaluate the safety, feasibility, and anti-tumor effects of a novel bone-targeted regimen consisting of Samarium Sm-153 lexidronam combined with docetaxel and prednisone. This present study design permits evaluation of the clinical activity of combining two distinct agents that have shown benefit for the treatment of patients with advanced androgen-independent prostate cancer and bone metastases. It enables assessment of potential synergistic interactions between a cytotoxic chemotherapy agent and a bone-targeting radioisotope agent in the setting of a bone-targeted therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Samarium Sm-153 lexidronam + Docetaxel |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Have histological evidence of adenocarcinoma of the prostate.
- Have progressive castrate metastatic disease.
- Castrate levels of testosterone (<50 ng/ml). Treatment to maintain castrate levels of testosterone must be continued.
- Must have evidence of at least 3 bone metastases on bone scan.
- Patients for whom initial hormone treatment (exclusive of neoadjuvant hormone therapy) was a combined androgen blockade approach, must show progression of disease following withdrawal of the anti-androgen prior to enrollment.
Key exclusion criteria (6 listed)
- Patients with small cell carcinoma.
- Patients with predominant visceral metastases (>3 lung or liver lesions) or symptomatic lymphadenopathy (scrotal or pedal edema).
- Patients who have received more than one course of external beam radiation therapy directed at bone lesions.
- Clinically significant cardiac disease (New York Heart Association Class III/IV).
- History of other malignancies (other than non-melanoma skin cancer), unless in complete remission or off therapy for that disease for at least five years.
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 |
|---|---|---|
| Samarium Sm-153 lexidronam + Docetaxel1 mCi/kg Sm153 + 75 mg/m2 docetaxel | Drug | 1 |
Primary outcome
Primary outcome is safety and tolerability of the combination treatment
1 secondary outcome
Tumor response will be assessed when possible using RECIST criteria.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2007.
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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.
Michael J Morris, M.D. principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Samarium Sm-153 lexidronam + Docetaxel in people with Prostatic Neoplasms, run by Cytogen Corporation 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 18 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Dec 2007. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colleen Gramkowski (800-833-3533 ext. 8219, cgramkowski@cytogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome is safety and tolerability of the combination treatment. 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 21 Dec 2007.